Non-small Cell Lung Cancer
Conditions
Keywords
Lung Neoplasms
Brief summary
The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).
Interventions
DRUGcarboplatin
AUC of 6 mg\*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices.
DRUGpaclitaxel
175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices.
DRUGsunitinib
50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after completing 1 year of treatment, pts deriving clinical benefit may continue to receive sunitinib in a separate continuation protocol).
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven NSCLC * Stage IIIB (locally advanced with malignant effusion) or Stage IV disease * No prior therapy for NSCLC * Evidence of unidimensionally measurable disease
Exclusion criteria
* Previous treatment with systemic chemotherapy for lung cancer * History of or known brain metastases * NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment * Evidence of hemoptysis within 4 weeks of starting study treatment * Serious acute or chronic illness or recent history of significant cardiac abnormality * Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of EGFR and PDGFR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Surviving at One Year | From start of treatment until 1 year or death | Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Tumor Progression (TTP) | From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) | TTP was defined as the time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02. |
| Duration of Response (DR) | From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death | DR=time from the first documentation of objective tumor response (complete response \[CR\] or partial response \[PR\]) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. CR=disappearance of all target lesions. PR=a \> = 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. If tumor progression data included more than 1 date, first date was used. DR (in weeks) was calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.02. |
| Number of Subjects With Overall Confirmed Objective Disease Response | From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) | Objective disease response = subjects with confirmed CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.0). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Overall Survival (OS) | From start of study treatment until death | OS was defined as the time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death - date of paclitaxel/carboplatin first dose +1)/30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of paclitaxel/carboplatin had their survival time censored at Day 1 of paclitaxel/carboplatin treatment. |
| Trough Plasma Concentration (Ctrough) of Sunitinib | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 | Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval. |
| Ctrough of SU-012662 (Sunitinib's Metabolite) | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 | Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval. |
| Ctrough of Total Drug (Sunitinib + SU-012662) | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 | Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval. |
| Dose-Corrected Ctrough of Sunitinib | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 | Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included. |
| Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 | Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included. |
| Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 | Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included. |
| Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline | Baseline (Cycle 1, Day 1) of Part 2 | Concentration of VEGFR3 at baseline. |
| VEGFR3 Ratio to Baseline at Each Time Point | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 | VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline). |
| VEGF-C Concentration at Baseline | Baseline (Cycle 1, Day 1) of Part 2 | Concentration of VEGF-C at baseline. |
| VEGF-C Ratio to Baseline at Each Time Point | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 | VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline). |
| Soluble E-Selectin at Baseline | Baseline (Cycle 1, Day 1) of Part 2 | Concentration of soluble E-Selectin at baseline. |
| Soluble E-Selectin Ratio to Baseline at Each Time Point | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 | Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline). |
| VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Baseline (Cycle 1, Day 1) of Part 2 | Median concentration of VEGFR3 at baseline stratified by tumor response (CR or PR or \[SD \> = 6 Weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality). |
| Progression-free Survival (PFS) | From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death | PFS was defined as the time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02. |
| VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Baseline (Cycle 1, Day 1) of Part 2 | Median concentration of VEGF-C at baseline stratified by tumor response (CR or PR or \[SD \> = 6 Weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality). |
| VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 | Median VEGF-C concentration at each time point divided by median VEGF-C concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 6 weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). |
| Immunohistochemical Staining of Paraffin Embedded Tumor Tissue | Screening | Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis. |
| Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Baseline (Cycle 1, Day 1) of Part 2 | Median concentration of soluble E-selectin at baseline stratified by tumor response (CR or PR or \[SD \> = 6 Weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality). |
| Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 | Median soluble E-selectin concentration at each time point divided by median soluble E-selectin concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 6 weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). |
| Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 | PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1)divided by 7.02. Groups are defined by \< or \> = median levels of VEGFR3 at Baseline and after Stratification by \< or \> = median changes from Baseline in VEGFR3 at each time point. |
| Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 | PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of VEGF-C at Baseline and after stratification by \< or \> = median changes from Baseline in VEGF-C at each time point. |
| Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | [Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 | PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of soluble E-selectin at Baseline and after stratification by \< or \> = median changes from Baseline in soluble E-selectin at each time point. |
| Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib | Within 7 days of Day 1 | A blood sample (6 mL) was collected and used to isolate DNA. These samples were not anonymized. |
| Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 | TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of VEGFR3 at Baseline and after stratification by \< or \> = median changes from baseline in VEGFR3 at each time point. |
| Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 | TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of VEGF-C at Baseline and after stratification by \< or \> = median changes from Baseline in VEGF-C at each time point. |
| Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 | TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of soluble E-selectin at Baseline and after stratification by \< or \> = median changes from Baseline in soluble E-selectin at each time point. |
| Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 | OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1)divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by \< or \> = median levels of VEGFR3 at Baseline and after stratification by \< or \> = median changes from Baseline in VEGFR3 at each time point. |
| Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 | OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by \< or \> = median levels of VEGF-C at Baseline and after stratification by \< or \> = median changes from Baseline in VEGF-C at each time point. |
| Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 | OS=time from start of study treatment to death due to any cause. OS (in months) calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring their survival times were censored at last date of known contact they were known to be alive. Subjects lacking data beyond day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by \< or \> = median levels of soluble E-selectin at Baseline and after stratification by \< or \> = median changes from Baseline in soluble E-selectin at each time point. |
| Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2 | EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1. |
| Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2 | QLQ-LC13 assessed lung cancer symptoms (dyspnea, coughing, dysphasia, hemoptysis, sore mouth, peripheral neuropathy, alopecia, chest pain, arm pain, shoulder pain, and pain in other parts). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1. |
| VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 | Median VEGFR3 concentration at each time point divided by median VEGFR3 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 6 weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). |
Countries
Canada, France, United States
Participant flow
Pre-assignment details
During Part 1, subjects received carboplatin plus paclitaxel 172-225 mg/m2. Those same subjects were eligible for continuation in Part 2 where they received sunitinib 50 mg. 66 subjects continued in Part 2.
Participants by arm
| Arm | Count |
|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg | 84 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Part 1 | Adverse Event | 6 | 0 |
| Part 1 | Death | 3 | 0 |
| Part 1 | Did Not Meet Entrance Criteria | 1 | 0 |
| Part 1 | Laboratory Abnormality | 1 | 0 |
| Part 1 | Lack of Efficacy | 2 | 0 |
| Part 1 | Missing | 65 | 0 |
| Part 1 | Ongoing | 1 | 0 |
| Part 1 | Other | 3 | 0 |
| Part 1 | Withdrawal by Subject | 2 | 0 |
| Part 2 | Adverse Event | 0 | 16 |
| Part 2 | Death | 0 | 5 |
| Part 2 | Laboratory Abnormality | 0 | 1 |
| Part 2 | Lack of Efficacy | 0 | 37 |
| Part 2 | Ongoing | 0 | 1 |
| Part 2 | Other | 0 | 3 |
| Part 2 | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | First Carboplatin Plus Paclitaxel, Then Sunitinib |
|---|---|
| Age, Customized < 65 years | 53 participants |
| Age, Customized > = 65 years | 31 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 82 / 84 | 60 / 66 |
| serious Total, serious adverse events | 29 / 84 | 29 / 66 |
Outcome results
Primary
Proportion of Subjects Surviving at One Year
Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.
Time frame: From start of treatment until 1 year or death
Population: Intent-to-treat (ITT) population = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Proportion of Subjects Surviving at One Year | 0.405 proportion |
Comparison: The study was designed to test the null hypothesis that the true one-year probability of survival is 0.40 versus the alternative hypothesis that the true one-year probability of survival is at least 0.55. The sample size was determined using a One-Sample Survival design, assuming alpha=0.05 (1-sided), power= 0.90, 6 month accrual, a minimum follow-up period of 12 months, and an expectation that approximately 5% of subjects may be lost to follow-up.90% CI: [0.315, 0.494]Kaplan-Meier
Secondary
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1.
Time frame: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
Population: ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Global Health Status /QoL (n=54) | -1.54 scores on a scale | Standard Error 3.58 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Global Health Status /QoL (n=42) | -9.13 scores on a scale | Standard Error 3.964 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Global Health Status /QoL (n=35) | -2.62 scores on a scale | Standard Error 3.361 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Global Health Status /QoL (n=21) | -9.13 scores on a scale | Standard Error 4.704 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Global Health Status /QoL (n=14) | 0.60 scores on a scale | Standard Error 7.175 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Global Health Status /QoL (n=10) | -2.50 scores on a scale | Standard Error 8.056 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Global Health Status /QoL (n=10) | 7.50 scores on a scale | Standard Error 4.883 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Physical Functioning (n=54) | -6.79 scores on a scale | Standard Error 2.806 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Physical Functioning (n=42) | -9.68 scores on a scale | Standard Error 2.363 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Physical Functioning (n=35) | -7.43 scores on a scale | Standard Error 2.941 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Physical Functioning (n=22) | -12.42 scores on a scale | Standard Error 4.771 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Physical Functioning (n=15) | -5.78 scores on a scale | Standard Error 3.178 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Physical Functioning (n=10) | -9.33 scores on a scale | Standard Error 7.647 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Physical Functioning (n=10) | -2.00 scores on a scale | Standard Error 5.072 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Role Functioning (n=54) | -16.05 scores on a scale | Standard Error 4.641 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Role Functioning (n=35) | -13.81 scores on a scale | Standard Error 4.95 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Role Functioning (n=22) | -28.03 scores on a scale | Standard Error 8.234 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Role Functioning (n=15) | -16.67 scores on a scale | Standard Error 7.968 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Role Functioning (n=10) | -15.00 scores on a scale | Standard Error 13.017 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Role Functioning (n=10) | 8.33 scores on a scale | Standard Error 11.18 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Emotional Functioning (n=54) | -2.16 scores on a scale | Standard Error 3.512 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Emotional Functioning (n=42) | 3.57 scores on a scale | Standard Error 3.139 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Emotional Functioning (n=35) | 1.90 scores on a scale | Standard Error 3.649 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Emotional Functioning (n=21) | 1.98 scores on a scale | Standard Error 4.668 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Emotional Functioning (n=14) | 13.10 scores on a scale | Standard Error 3.571 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Emotional Functioning (n=10) | 12.50 scores on a scale | Standard Error 4.348 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Emotional Functioning (n=10) | 24.17 scores on a scale | Standard Error 5.038 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Cognitive Functioning (n=54) | -8.95 scores on a scale | Standard Error 3.138 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Cognitive Functioning (n=42) | -3.57 scores on a scale | Standard Error 3.704 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Cognitive Functioning (n=35) | -10.00 scores on a scale | Standard Error 3.817 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Cognitive Functioning (n=21) | -10.32 scores on a scale | Standard Error 5.573 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Cognitive Functioning (n=14) | 1.19 scores on a scale | Standard Error 3.692 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Cognitive Functioning (n=10) | -1.67 scores on a scale | Standard Error 4.615 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Cognitive Functioning (n=10) | 5.00 scores on a scale | Standard Error 5 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Social Functioning (n=53) | -11.64 scores on a scale | Standard Error 4.25 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Social Functioning (n=41) | -10.98 scores on a scale | Standard Error 5.417 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Social Functioning (n=34) | -9.31 scores on a scale | Standard Error 5.228 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Social Functioning (n=20) | -25.00 scores on a scale | Standard Error 7.204 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Social Functioning (n=14) | -7.14 scores on a scale | Standard Error 5.98 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Social Functioning (n=10) | -8.33 scores on a scale | Standard Error 11.453 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Social Functioning (n=10) | 1.67 scores on a scale | Standard Error 7.222 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Fatigue (n=54) | 13.48 scores on a scale | Standard Error 3.411 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Fatigue (n=42) | 16.40 scores on a scale | Standard Error 3.921 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Fatigue (n=35) | 8.25 scores on a scale | Standard Error 4.083 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Fatigue (n=22) | 19.70 scores on a scale | Standard Error 6.025 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Fatigue (n=15) | 8.15 scores on a scale | Standard Error 6.548 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Fatigue (n=10) | 22.22 scores on a scale | Standard Error 11.355 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Nausea and Vomiting (n=54) | 5.56 scores on a scale | Standard Error 2.988 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Nausea and Vomiting (n=42) | 11.90 scores on a scale | Standard Error 3.822 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Nausea and Vomiting (n=35) | 6.67 scores on a scale | Standard Error 4.491 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Nausea and Vomiting (n=22) | 6.82 scores on a scale | Standard Error 4.608 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Nausea and Vomiting (n=15) | 5.56 scores on a scale | Standard Error 5.789 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Dyspnea (n=15) | -8.89 scores on a scale | Standard Error 3.94 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Role Functioning (n=42) | -20.63 scores on a scale | Standard Error 5.383 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Fatigue (n=10) | -1.11 scores on a scale | Standard Error 7.49 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Nausea and Vomiting (n=10) | 11.67 scores on a scale | Standard Error 7.049 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Nausea and Vomiting (n=10) | 1.67 scores on a scale | Standard Error 6.31 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Pain (n=54) | 3.09 scores on a scale | Standard Error 4.228 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Pain (n=42) | -0.79 scores on a scale | Standard Error 3.766 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Pain (n=35) | 5.24 scores on a scale | Standard Error 4.572 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Pain (n=22) | 0.76 scores on a scale | Standard Error 5.748 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Pain (n=15) | 5.56 scores on a scale | Standard Error 6.64 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Pain (n=10) | -1.67 scores on a scale | Standard Error 8.767 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Pain (n=10) | -3.33 scores on a scale | Standard Error 7.778 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Dyspnea (n=54) | 2.47 scores on a scale | Standard Error 3.396 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Dyspnea (n=42) | 1.59 scores on a scale | Standard Error 3.76 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Dyspnea (n=35) | -4.76 scores on a scale | Standard Error 4.352 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Dyspnea (n=22) | -13.64 scores on a scale | Standard Error 6.454 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Dyspnea (n=10) | 0.00 scores on a scale | Standard Error 8.607 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Dyspnea (n=10) | -13.33 scores on a scale | Standard Error 7.37 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Insomnia (n=54) | -3.09 scores on a scale | Standard Error 5.006 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Insomnia (n=42) | -5.56 scores on a scale | Standard Error 5.671 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Insomnia (n=35) | -2.86 scores on a scale | Standard Error 5.529 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Insomnia (n=22) | 6.06 scores on a scale | Standard Error 8.672 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Insomnia (n=15) | -2.22 scores on a scale | Standard Error 6.057 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Insomnia (n=10) | 6.67 scores on a scale | Standard Error 10.887 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Insomnia (n=10) | -20.00 scores on a scale | Standard Error 7.37 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Appetite Loss (n=54) | 11.11 scores on a scale | Standard Error 5.138 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Appetite Loss (n=42) | 20.63 scores on a scale | Standard Error 5.898 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Appetite Loss (n=35) | 13.33 scores on a scale | Standard Error 7.633 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Appetite Loss (n=22) | 10.61 scores on a scale | Standard Error 7.068 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Appetite Loss (n=15) | 2.22 scores on a scale | Standard Error 7.606 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Appetite Loss (n=10) | 13.3 scores on a scale | Standard Error 12.373 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Appetite Loss (n=10) | -6.67 scores on a scale | Standard Error 10.887 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Constipation (n=54) | 5.56 scores on a scale | Standard Error 4.109 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Constipation (n=42) | -0.79 scores on a scale | Standard Error 5.266 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Constipation (n=35) | 13.33 scores on a scale | Standard Error 4.965 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Constipation (n=22) | -4.55 scores on a scale | Standard Error 6.317 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Constipation (n=15) | -4.44 scores on a scale | Standard Error 6.397 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Constipation (n=10) | -6.67 scores on a scale | Standard Error 6.667 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Constipation (n=10) | -10.00 scores on a scale | Standard Error 5.092 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Diarrhea (n=54) | -3.09 scores on a scale | Standard Error 2.206 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Diarrhea (n=41) | 13.01 scores on a scale | Standard Error 5.058 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Diarrhea (n=35) | 11.43 scores on a scale | Standard Error 4.916 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Diarrhea (n=21) | 7.94 scores on a scale | Standard Error 5.589 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Diarrhea (n=14) | 16.67 scores on a scale | Standard Error 6.767 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Diarrhea (n=10) | 26.67 scores on a scale | Standard Error 9.686 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Diarrhea (n=10) | 0.00 scores on a scale | Standard Error 9.938 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 1 Financial Difficulties (n=54) | 5.56 scores on a scale | Standard Error 2.607 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 1, Day 28 Financial Difficulties (n=42) | 2.38 scores on a scale | Standard Error 2.381 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 1 Financial Difficulties (n=34) | 5.88 scores on a scale | Standard Error 4.331 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 2, Day 28 Financial Difficulties (n=21) | 6.35 scores on a scale | Standard Error 5.453 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 1 Financial Difficulties (n=14) | 11.90 scores on a scale | Standard Error 7.5 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 3, Day 28 Financial Difficulties (n=10) | 13.33 scores on a scale | Standard Error 10.184 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | Cycle 4, Day 1 Financial Difficulties (n=10) | 13.33 scores on a scale | Standard Error 10.184 |
Secondary
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13)
QLQ-LC13 assessed lung cancer symptoms (dyspnea, coughing, dysphasia, hemoptysis, sore mouth, peripheral neuropathy, alopecia, chest pain, arm pain, shoulder pain, and pain in other parts). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1.
Time frame: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
Population: ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 1 Dyspnea (n=49) | 3.40 scores on a scale | Standard Error 3.008 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 28 Dyspnea (n=37) | 4.80 scores on a scale | Standard Error 3.03 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 1 Dyspnea (n=31) | 4.30 scores on a scale | Standard Error 4.112 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 28 Dyspnea (n=21) | 1.59 scores on a scale | Standard Error 4.49 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 1 Dyspnea (n=14) | -1.59 scores on a scale | Standard Error 3.466 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 28 Dyspnea (n=9) | 4.94 scores on a scale | Standard Error 6.705 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 4, Day 1 Dyspnea (n=9) | 0.00 scores on a scale | Standard Error 3.208 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 1 Coughing (n=53) | -14.47 scores on a scale | Standard Error 5.12 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 28 Coughing (n=40) | -14.17 scores on a scale | Standard Error 5.048 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 1 Coughing (n=34) | -12.75 scores on a scale | Standard Error 5.077 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 28 Coughing (n=21) | -15.87 scores on a scale | Standard Error 7.496 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 1 Coughing (n=14) | -9.52 scores on a scale | Standard Error 5.445 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 28 Coughing (n=10) | -13.33 scores on a scale | Standard Error 7.37 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 4, Day 1 Coughing (n=9) | -11.11 scores on a scale | Standard Error 7.857 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 1 Hemoptysis (n=53) | 0.63 scores on a scale | Standard Error 1.678 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 28 Hemoptysis (n=39) | 5.13 scores on a scale | Standard Error 3.362 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 1 Hemoptysis (n=33) | 2.02 scores on a scale | Standard Error 1.406 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 28 Hemoptysis (n=21) | -1.59 scores on a scale | Standard Error 2.795 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 1 Hemoptysis (n=14) | -2.38 scores on a scale | Standard Error 2.381 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 28 Hemoptysis (n=10) | 0.00 scores on a scale | Standard Error 0 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 4, Day 1 Hemoptysis (n=9) | -3.70 scores on a scale | Standard Error 3.704 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 1 Sore Mouth (n=53) | -5.66 scores on a scale | Standard Error 3.782 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 28 Sore Mouth (n=40) | 20.00 scores on a scale | Standard Error 7.141 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 1 Sore Mouth (n=34) | 9.80 scores on a scale | Standard Error 7.111 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 28 Sore Mouth (n=21) | 12.70 scores on a scale | Standard Error 6.289 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 1 Sore Mouth (n=14) | 0.00 scores on a scale | Standard Error 3.494 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 28 Sore Mouth (n=10) | 10.00 scores on a scale | Standard Error 13.194 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 4, Day 1 Sore Mouth (n=9) | -11.11 scores on a scale | Standard Error 7.857 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 1 Dysphasia (n=53) | -0.63 scores on a scale | Standard Error 3.298 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 28 Dysphasia (n=40) | 7.50 scores on a scale | Standard Error 4.697 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 1 Dysphasia (n=34) | 2.94 scores on a scale | Standard Error 5.145 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 28 Dysphasia (n=21) | -1.59 scores on a scale | Standard Error 2.795 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 1 Dysphasia (n=14) | -4.76 scores on a scale | Standard Error 4.762 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 28 Dysphasia (n=10) | -10.00 scores on a scale | Standard Error 5.092 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 4, Day 1 Dysphasia (n=9) | -11.11 scores on a scale | Standard Error 5.556 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 1 Peripheral Neuropathy (n=53) | 42.14 scores on a scale | Standard Error 5.012 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 28 Peripheral Neuropathy (n=40) | 32.50 scores on a scale | Standard Error 5.402 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 1 Peripheral Neuropathy (n=34) | 28.43 scores on a scale | Standard Error 5.825 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 28 Peripheral Neuropathy (n=21) | 26.98 scores on a scale | Standard Error 7.841 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 1 Peripheral Neuropathy (n=14) | 23.81 scores on a scale | Standard Error 10.145 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 28 Peripheral Neuropathy (n=10) | 20.00 scores on a scale | Standard Error 10.184 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 4, Day 1 Peripheral Neuropathy (n=9) | 7.41 scores on a scale | Standard Error 7.407 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 1 Alopecia (n=53) | 63.52 scores on a scale | Standard Error 5.407 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 28 Alopecia (n=40) | 40.83 scores on a scale | Standard Error 7.009 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 1 Alopecia (n=34) | 30.39 scores on a scale | Standard Error 7.627 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 28 Alopecia (n=20) | 11.67 scores on a scale | Standard Error 7.752 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 1 Alopecia (n=14) | 0.00 scores on a scale | Standard Error 0 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 28 Alopecia (n=10) | 0.00 scores on a scale | Standard Error 0 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 4, Day 1 Alopecia (n=9) | 0.00 scores on a scale | Standard Error 0 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 1 Pain in Chest (n=53) | -8.18 scores on a scale | Standard Error 3.581 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 28 Pain in Chest (n=40) | -4.17 scores on a scale | Standard Error 3.415 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 1 Pain in Chest (n=34) | -0.98 scores on a scale | Standard Error 3.85 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 28 Pain in Chest (n=21) | 0.00 scores on a scale | Standard Error 3.984 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 1 Pain in Chest (n=14) | 4.76 scores on a scale | Standard Error 5.906 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 28 Pain in Chest (n=10) | 0.00 scores on a scale | Standard Error 7.027 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 4, Day 1 Pain in Chest (n=9) | 7.41 scores on a scale | Standard Error 9.259 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 1 Pain in Arm or Shoulder (n=51) | -1.31 scores on a scale | Standard Error 4.171 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 28 Pain in Arm or Shoulder (n=39) | 0.85 scores on a scale | Standard Error 4.497 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 1 Pain in Arm or Shoulder (n=34) | 3.92 scores on a scale | Standard Error 6.257 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 28 Pain in Arm or Shoulder (n=21) | 3.17 scores on a scale | Standard Error 4.545 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 1 Pain in Arm or Shoulder (n=14) | 2.38 scores on a scale | Standard Error 4.228 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 28 Pain in Arm or Shoulder (n=10) | -6.67 scores on a scale | Standard Error 11.967 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 4, Day 1 Pain in Arm or Shoulder (n=9) | -11.11 scores on a scale | Standard Error 11.111 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 1 Pain in Other Parts (n=47) | 3.55 scores on a scale | Standard Error 6.431 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 1, Day 28 Pain in Other Parts (n=35) | -6.67 scores on a scale | Standard Error 5.925 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 1 Pain in Other Parts (n=27) | 12.35 scores on a scale | Standard Error 7.368 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 2, Day 28 Pain in Other Parts (n=17) | 13.73 scores on a scale | Standard Error 8.603 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 1 Pain in Other Parts (n=14) | 11.90 scores on a scale | Standard Error 8.274 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 3, Day 28 Pain in Other Parts (n=9) | -11.11 scores on a scale | Standard Error 9.623 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | Cycle 4, Day 1 Pain in Other Parts (n=9) | 0.00 scores on a scale | Standard Error 9.623 |
Secondary
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline
OS=time from start of study treatment to death due to any cause. OS (in months) calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring their survival times were censored at last date of known contact they were known to be alive. Subjects lacking data beyond day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by \< or \> = median levels of soluble E-selectin at Baseline and after stratification by \< or \> = median changes from Baseline in soluble E-selectin at each time point.
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (\< median cutpoint), Cycle 4, Day 28 (\< median cutpoint, \> = median cutpoint)and Cycle 5, Day 28 (\< median cutpoint), median and/or CI were not able to be estimated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 1, Day 1 (< Median Cutpoint, n=26) | 6.5 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 1, Day 28 (< Median Cutpoint, n=17) | 8.7 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 1, Day 28 (> = Median Cutpoint, n=17) | 6.5 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 2, Day 1 (< Median Cutpoint, n=14) | 11.2 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 2, Day 1 (> = Median Cutpoint, n=15) | 8.5 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 2, Day 28 (< Median Cutpoint, n=11) | 8.0 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 2, Day 28 (> = Median Cutpoint, n=11) | 14.8 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 3, Day 1 (> = Median Cutpoint, n=8) | 12.7 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 3, Day 28 (> = Median Cutpoint, n=4) | 15.3 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 5, Day 28 (> = Median Cutpoint, n=2) | 13.8 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 1, Day 1 (> = Median Cutpoint, n=27) | 8.0 months |
Comparison: Cycle 1, Day 1p-value: 0.76695% CI: [0.51, 1.65]Log Rank
Comparison: Cycle 1, Day 28p-value: 0.268295% CI: [0.72, 3.23]Log Rank
Comparison: Cycle 2, Day 1p-value: 0.272695% CI: [0.69, 3.7]Log Rank
Comparison: Cycle 2, Day 28p-value: 0.278795% CI: [0.22, 1.55]Log Rank
Comparison: Cycle 3, Day 1p-value: 0.024195% CI: [1.09, 17.56]Log Rank
Comparison: Cycle 3, Day 28p-value: 0.094395% CI: [0.59, 48.81]Log Rank
Comparison: Cycle 5, Day 28p-value: 0.808495% CI: [0.04, 11.79]Log Rank
Secondary
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by \< or \> = median levels of VEGF-C at Baseline and after stratification by \< or \> = median changes from Baseline in VEGF-C at each time point.
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (\> = median cutpoint), median and/or CI were not able to be estimated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 1 (< Median Cutpoint, n=29) | 8.5 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 1 (> = Median Cutpoint, n=30) | 5.2 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 28 (> = Median Cutpoint, n=23) | 8.8 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 1 (< Median Cutpoint, n=19) | 9.7 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 1 (> = Median Cutpoint, n=20) | 12.7 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 28 (< Median Cutpoint, n=15) | 8.0 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 28 (> = Median Cutpoint, n=15) | 14.8 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 3, Day 1 (< Median Cutpoint, n=10) | 10.2 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 3, Day 1 (> = Median Cutpoint, n=10) | 15.8 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 3, Day 28 (< Median Cutpoint, n=6) | 14.2 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 5, Day 28 (< Median Cutpoint, n=2) | 14.2 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 5, Day 28 (> = Median Cutpoint, n=2) | 16.6 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 28 (< Median Cutpoint, n=23) | 8.5 months |
Comparison: Cycle 1, Day 1p-value: 0.426995% CI: [0.72, 2.21]Log Rank
Comparison: Cycle 1, Day 28p-value: 0.92995% CI: [0.51, 1.86]Log Rank
Comparison: Cycle 2, Day 1p-value: 0.819595% CI: [0.44, 1.91]Log Rank
Comparison: Cycle 2, Day 28p-value: 0.22195% CI: [0.26, 1.38]Log Rank
Comparison: Cycle 3, Day 1p-value: 0.429795% CI: [0.24, 1.85]Log Rank
Comparison: Cycle 3, Day 28p-value: 0.052295% CI: [0.06, 1.11]Log Rank
Comparison: Cycle 5, Day 28p-value: 0.694995% CI: [0.05, 7]Log Rank
Secondary
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline
OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1)divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by \< or \> = median levels of VEGFR3 at Baseline and after stratification by \< or \> = median changes from Baseline in VEGFR3 at each time point.
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (\< median cutpoint), median and/or CI were not able to be estimated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 1, Day 1 (< Median Cutpoint, n=30) | 8.7 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 1, Day 1 (> = Median Cutpoint, n=30) | 6.1 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 1, Day 28 (< Median Cutpoint, n=23) | 14.7 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 1, Day 28 (> = Median Cutpoint, n=23) | 7.1 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 2, Day 1 (< Median Cutpoint, n=20) | 13.7 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 2, Day 1 (> = Median Cutpoint, n=20) | 8.8 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 2, Day 28 (< Median Cutpoint, n=14) | 11.2 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 2, Day 28 (> = Median Cutpoint, n=15) | 13.3 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 3, Day 1 (> = Median Cutpoint, n=11) | 7.4 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 3, Day 28 (< Median Cutpoint, n=6) | 17.7 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 5, Day 28 (< Median Cutpoint, n=2) | 17.1 months |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | Cycle 5, Day 28 (> = Median Cutpoint, n=2) | 13.8 months |
Comparison: Cycle 1, Day 1p-value: 0.476895% CI: [0.7, 2.17]Log Rank
Comparison: Cycle 1, Day 28p-value: 0.148495% CI: [0.84, 3.13]Log Rank
Comparison: Cycle 2, Day 1p-value: 0.895795% CI: [0.5, 2.18]Log Rank
Comparison: Cycle 2, Day 28p-value: 0.568195% CI: [0.33, 1.85]Log Rank
Comparison: Cycle 3, Day 1p-value: 0.007495% CI: [1.35, 10.88]Log Rank
Comparison: Cycle 3, Day 28p-value: 0.163795% CI: [0.06, 1.7]Log Rank
Comparison: Cycle 5, Day 28p-value: 0.432895% CI: [0.23, 29.12]Log Rank
Secondary
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline
PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of soluble E-selectin at Baseline and after stratification by \< or \> = median changes from Baseline in soluble E-selectin at each time point.
Time frame: [Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (\> = median cutpoint), Cycle 3, Day 28 (\< median cutpoint), and Cycles 4 and 5, Day 28 (\< median cutpoint, \> = median cutpoint), median and/or CI were not able to be estimated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 1, Day 1 (< Median Cutpoint, n=26) | 11.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 1, Day 1 (> = Median Cutpoint, n=27) | 11.0 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 1, Day 28 (< Median Cutpoint, n=17) | 11.0 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 1, Day 28 (> = Median Cutpoint, n=17) | 10.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 2, Day 1 (< Median Cutpoint, n=14) | 11.0 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 2, Day 1 (> = Median Cutpoint, n=15) | 16.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 2, Day 28 (< Median Cutpoint, n=11) | 11.0 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 3, Day 1 (< Median Cutpoint, n=8) | 33.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 3, Day 1 (> = Median Cutpoint, n=8) | 22.5 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | Cycle 3, Day 28 (> = Median Cutpoint, n=4) | 43.3 weeks |
Comparison: Cycle 1, Day 28p-value: 0.46695% CI: [0.58, 3.29]Log Rank
Comparison: Cycle 1, Day 1p-value: 0.527795% CI: [0.39, 1.62]Log Rank
Comparison: Cycle 2, Day 1p-value: 0.533795% CI: [0.52, 3.44]Log Rank
Comparison: Cycle 2, Day 28p-value: 0.071295% CI: [0.13, 1.13]Log Rank
Comparison: Cycle 3, Day 1p-value: 0.294895% CI: [0.54, 7.07]Log Rank
Comparison: Cycle 3, Day 28p-value: 0.3295% CI: [0.28, 38.48]Log Rank
Secondary
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of VEGF-C at Baseline and after stratification by \< or \> = median changes from Baseline in VEGF-C at each time point.
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (\< median cutpoint) and Cycle 5, Day 28 (\< median cutpoint), median and/or CI were not able to be estimated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 1 (< Median Cutpoint, n=29) | 16.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 1 (> = Median Cutpoint, n=30) | 10.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 28 (< Median Cutpoint, n=23) | 12.4 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 28 (> = Median Cutpoint, n=23) | 11.0 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 1 (< Median Cutpoint, n=19) | 13.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 1 (> = Median Cutpoint, n=20) | 16.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 28 (< Median Cutpoint, n=15) | 10.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 28 (> = Median Cutpoint, n=15) | 31.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 3, Day 1 (< Median Cutpoint, n=10) | 19.7 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 3, Day 1 (> = Median Cutpoint, n=10) | 30.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 3, Day 28 (> = Median Cutpoint, n=6) | 32.9 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 5, Day 28 (> = Median Cutpoint, n=2) | 37.0 weeks |
Comparison: Cycle 1, Day 1p-value: 0.50795% CI: [0.65, 2.39]Log Rank
Comparison: Cycle 1, Day 28p-value: 0.447495% CI: [0.63, 2.82]Log Rank
Comparison: Cycle 2, Day 1p-value: 0.759995% CI: [0.4, 1.95]Log Rank
Comparison: Cycle 2, Day 28p-value: 0.010995% CI: [0.12, 0.8]Log Rank
Comparison: Cycle 3, Day 1p-value: 0.687895% CI: [0.43, 3.58]Log Rank
Comparison: Cycle 3, Day 28p-value: 0.463795% CI: [0.38, 8.12]Log Rank
Secondary
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline
PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1)divided by 7.02. Groups are defined by \< or \> = median levels of VEGFR3 at Baseline and after Stratification by \< or \> = median changes from Baseline in VEGFR3 at each time point.
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (\< median cutpoint) and Cycle 5, Day 28 (\> = median cutpoint), median and/or CI were not able to be estimated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 1, Day 1 (< Median Cutpoint, n=30) | 13.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 1, Day 1 (> = Median Cutpoint, n=30) | 10.3 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 1, Day 28 (< Median Cutpoint, n=23) | 15.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 1, Day 28 (> = Median Cutpoint, n=23) | 10.3 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 2, Day 1 (< Median Cutpoint, n=20) | 22.5 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 2, Day 1 (> = Median Cutpoint, n=20) | 11.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 2, Day 28 (< Median Cutpoint, n=14) | 16.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 2, Day 28 (> = Median Cutpoint, n=15) | 16.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 3, Day 1 (< Median Cutpoint, n=10) | 32.9 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 3, Day 1 (> = Median Cutpoint, n=11) | 16.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 3, Day 28 (> = Median Cutpoint, n=6) | 32.9 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 5, Day 28 (< Median Cutpoint, n=2) | 38.3 weeks |
Comparison: Cycle 1, Day 1p-value: 0.678295% CI: [0.61, 2.15]Log Rank
Comparison: Cycle 1, Day 28p-value: 0.19895% CI: [0.77, 3.3]Log Rank
Comparison: Cycle 2, Day 1p-value: 0.134495% CI: [0.82, 3.98]Log Rank
Comparison: Cycle 2, Day 28p-value: 0.480995% CI: [0.56, 3.39]Log Rank
Comparison: Cycle 3, Day 1p-value: 0.015395% CI: [1.19, 11.13]Log Rank
Comparison: Cycle 3, Day 28p-value: 0.208595% CI: [0.52, 14.37]Log Rank
Comparison: Cycle 5, Day 28p-value: 0.808495% CI: [0.08, 23.57]Log Rank
Secondary
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline
TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of soluble E-selectin at Baseline and after stratification by \< or \> = median changes from Baseline in soluble E-selectin at each time point.
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (\> = median cutpoint), Cycle 3, Day 28 (\< median cutpoint), and Cycles 4 and 5, Day 28 (\< median cutpoint, \> = median cutpoint), median and/or CI were not able to be estimated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | Cycle 1, Day 1 (< Median Cutpoint, n=26) | 11.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | Cycle 1, Day 1 (> = Median Cutpoint, n=27) | 12.4 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | Cycle 1, Day 28 (< Median Cutpoint, n=17) | 11.0 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | Cycle 2, Day 1 (< Median Cutpoint, n=14) | 11.0 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | Cycle 2, Day 1 (> = Median Cutpoint, n=15) | 16.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | Cycle 2, Day 28 (< Median Cutpoint, n=11) | 11.0 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | Cycle 3, Day 1 (< Median Cutpoint, n=8) | 33.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | Cycle 3, Day 1 (> = Median Cutpoint n=8) | 33.9 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | Cycle 3, Day 28 (> = Median Cutpoint, n=4) | 43.3 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | Cycle 1, Day 28 (> = Median Cutpoint, n=17) | 10.1 weeks |
Comparison: Cycle 1, Day 1p-value: 0.668295% CI: [0.39, 1.84]Log Rank
Comparison: Cycle 1, Day 28p-value: 0.685495% CI: [0.49, 3]Log Rank
Comparison: Cycle 2, Day 1p-value: 0.602895% CI: [0.49, 3.37]Log Rank
Comparison: Cycle 2, Day 28p-value: 0.071295% CI: [0.13, 1.13]Log Rank
Comparison: Cycle 3, Day 1p-value: 0.341195% CI: [0.5, 7.15]Log Rank
Comparison: Cycle 3, Day 28p-value: 0.3295% CI: [0.28, 38.48]Log Rank
Secondary
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of VEGF-C at Baseline and after stratification by \< or \> = median changes from Baseline in VEGF-C at each time point.
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (\< median cutpoint), and Cycle 5, Day 28 (\< median cutpoint, \> = median cutpoint), median and/or CI were not able to be estimated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 1 (> = Median Cutpoint, n=30) | 10.3 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 28 (< Median Cutpoint, n=23) | 15.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 28 (> = Median Cutpoint, n=23) | 11.0 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 1 (< Median Cutpoint, n=19) | 13.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 1 (> = Median Cutpoint, n=20) | 16.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 28 (< Median Cutpoint, n=15) | 10.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 2, Day 28 (> = Median Cutpoint, n=15) | 31.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 3, Day 1 (< Median Cutpoint, n=10) | 16.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 3, Day 1 (> = Median Cutpoint, n=10) | 30.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 3, Day 28 (> = Median Cutpoint, n=6) | 32.9 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 5, Day 28 (> = Median Cutpoint, n=2) | 37.0 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | Cycle 1, Day 1 (< Median Cutpoint, n=29) | 16.1 weeks |
Comparison: Cycle 1, Day 1p-value: 0.521595% CI: [0.62, 2.53]Log Rank
Comparison: Cycle 1, Day 28p-value: 0.250495% CI: [0.72, 3.49]Log Rank
Comparison: Cycle 2, Day 1p-value: 0.876695% CI: [0.42, 2.11]Log Rank
Comparison: Cycle 2, Day 28p-value: 0.010995% CI: [0.12, 0.8]Log Rank
Comparison: Cycle 3, Day 1p-value: 0.562795% CI: [0.46, 4.18]Log Rank
Comparison: Cycle 3, Day 28p-value: 0.463795% CI: [0.38, 8.12]Log Rank
Secondary
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline
TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of VEGFR3 at Baseline and after stratification by \< or \> = median changes from baseline in VEGFR3 at each time point.
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (\< median cutpoint) and Cycle 5, Day 28 (\> = median cutpoint), median and/or CI were not able to be estimated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 1, Day 1 (< Median Cutpoint, n=30) | 15.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 1, Day 1 (> = Median Cutpoint, n=30) | 11.0 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 1, Day 28 (< Median Cutpoint, n=23) | 15.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 1, Day 28 (> = Median Cutpoint, n=23) | 12.4 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 2, Day 1 (< Median Cutpoint, n=20) | 30.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 2, Day 1 (> = Median Cutpoint, n=20) | 11.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 2, Day 28 (< Median Cutpoint, n=14) | 16.8 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 2, Day 28 (> = Median Cutpoint, n=15) | 16.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 3, Day 1 (< Median Cutpoint, n=10) | 32.9 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 3, Day 1 (> = Median Cutpoint, n=11) | 16.1 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 3, Day 28 (> = Median Cutpoint, n=6) | 32.9 weeks |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | Cycle 5, Day 28 (< Median Cutpoint, n=2) | 38.3 weeks |
Comparison: Cycle 1, Day 1p-value: 0.782495% CI: [0.56, 2.17]Log Rank
Comparison: Cycle 1, Day 28p-value: 0.191895% CI: [0.77, 3.47]Log Rank
Comparison: Cycle 2, Day 1p-value: 0.109395% CI: [0.85, 4.3]Log Rank
Comparison: Cycle 2, Day 28p-value: 0.480995% CI: [0.56, 3.39]Log Rank
Comparison: Cycle 3, Day 1p-value: 0.01195% CI: [1.26, 13.85]Log Rank
Comparison: Cycle 3, Day 28p-value: 0.208595% CI: [0.52, 14.37]Log Rank
Comparison: Cycle 5, Day 28p-value: 0.808495% CI: [0.08, 23.57]Log Rank
Secondary
Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib
A blood sample (6 mL) was collected and used to isolate DNA. These samples were not anonymized.
Time frame: Within 7 days of Day 1
Population: c-Kit, Flt-3 and c-Fms to safety of Sunitinib samples were collected and analyzed. However, there was no statistics performed since power was insufficient.
Secondary
Ctrough of SU-012662 (Sunitinib's Metabolite)
Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.
Time frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Population: PK. Subjects with plasma values below limit of quantification were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Ctrough of SU-012662 (Sunitinib's Metabolite) | Cycle 1, Day 28 (n=51) | 27.54 ng/mL | Standard Deviation 15.1 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Ctrough of SU-012662 (Sunitinib's Metabolite) | Cycle 2, Day 28 (n=36) | 23.47 ng/mL | Standard Deviation 20.99 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Ctrough of SU-012662 (Sunitinib's Metabolite) | Cycle 3, Day 28 (n=16) | 18.37 ng/mL | Standard Deviation 9.05 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Ctrough of SU-012662 (Sunitinib's Metabolite) | Cycle 5, Day 28 (n=6) | 15.67 ng/mL | Standard Deviation 7.12 |
Secondary
Ctrough of Total Drug (Sunitinib + SU-012662)
Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.
Time frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Population: PK. Subjects with plasma values below limit of quantification were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Ctrough of Total Drug (Sunitinib + SU-012662) | Cycle 1, Day 28 (n=51) | 85.23 ng/mL | Standard Deviation 42.22 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Ctrough of Total Drug (Sunitinib + SU-012662) | Cycle 2, Day 28 (n=36) | 74.35 ng/mL | Standard Deviation 51.6 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Ctrough of Total Drug (Sunitinib + SU-012662) | Cycle 3, Day 28 (n=16) | 59.92 ng/mL | Standard Deviation 30.72 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Ctrough of Total Drug (Sunitinib + SU-012662) | Cycle 5, Day 28 (n=6) | 54.24 ng/mL | Standard Deviation 27.9 |
Secondary
Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.
Time frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Population: PK. Subjects with plasma values below limit of quantification were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) | Cycle 1, Day 28 (n=39) | 27.90 ng/mL | Standard Deviation 14.66 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) | Cycle 2, Day 28 (n=28) | 27.37 ng/mL | Standard Deviation 30.55 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) | Cycle 3, Day 28 (n=13) | 20.64 ng/mL | Standard Deviation 9.97 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) | Cycle 5, Day 28 (n=5) | 22.29 ng/mL | Standard Deviation 8.35 |
Secondary
Dose-Corrected Ctrough of Sunitinib
Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.
Time frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Population: PK. Subjects with plasma values below limit of quantification were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of Sunitinib | Cycle 1, Day 28 (n=39) | 64.10 ng/mL | Standard Deviation 26.84 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of Sunitinib | Cycle 2, Day 28 (n=28) | 59.85 ng/mL | Standard Deviation 40.45 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of Sunitinib | Cycle 3, Day 28 (n=13) | 49.59 ng/mL | Standard Deviation 21.86 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of Sunitinib | Cycle 5, Day 28 (n=5) | 54.51 ng/mL | Standard Deviation 13.67 |
Secondary
Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)
Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.
Time frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Population: PK. Subjects with plasma values below limit of quantification were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) | Cycle 1, Day 28 (n=39) | 92.00 ng/mL | Standard Deviation 40.31 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) | Cycle 2, Day 28 (n=28) | 87.22 ng/mL | Standard Deviation 68.28 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) | Cycle 3, Day 28 (n=13) | 70.24 ng/mL | Standard Deviation 28.71 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) | Cycle 5, Day 28 (n=5) | 76.80 ng/mL | Standard Deviation 20.13 |
Secondary
Duration of Response (DR)
DR=time from the first documentation of objective tumor response (complete response \[CR\] or partial response \[PR\]) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. CR=disappearance of all target lesions. PR=a \> = 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. If tumor progression data included more than 1 date, first date was used. DR (in weeks) was calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.02.
Time frame: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death
Population: ITT. DR was calculated for the subgroup of subjects with objective response. 23 subjects reported CR or PR response and were analyzed for DR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Duration of Response (DR) | 27.3 weeks |
Secondary
Immunohistochemical Staining of Paraffin Embedded Tumor Tissue
Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis.
Time frame: Screening
Population: Samples were collected and stained from a subset of subjects. Due to the small sample size, no correlative analyses with clinical outcome were conducted.
Secondary
Number of Subjects With Overall Confirmed Objective Disease Response
Objective disease response = subjects with confirmed CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.0). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time frame: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Number of Subjects With Overall Confirmed Objective Disease Response | 23 participants |
95% CI: [18.2, 38.2]
Secondary
Overall Survival (OS)
OS was defined as the time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death - date of paclitaxel/carboplatin first dose +1)/30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of paclitaxel/carboplatin had their survival time censored at Day 1 of paclitaxel/carboplatin treatment.
Time frame: From start of study treatment until death
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Overall Survival (OS) | 10.4 months |
Secondary
Progression-free Survival (PFS)
PFS was defined as the time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.
Time frame: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Progression-free Survival (PFS) | 23.1 weeks |
Secondary
Soluble E-Selectin at Baseline
Concentration of soluble E-Selectin at baseline.
Time frame: Baseline (Cycle 1, Day 1) of Part 2
Population: MITT. Number of participants analyzed = number of subjects with soluble E-Selectin data at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin at Baseline | 27.06 nanograms (ng)/mL | Standard Deviation 11.474 |
Secondary
Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Median concentration of soluble E-selectin at baseline stratified by tumor response (CR or PR or \[SD \> = 6 Weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).
Time frame: Baseline (Cycle 1, Day 1) of Part 2
Population: MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 1 (CR or PR or SD, n=17) | 26.40 pg/mL |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 1 (PD, n=21) | 27.40 pg/mL |
p-value: 0.537Wilcoxon Rank Sum Test
Secondary
Soluble E-Selectin Ratio to Baseline at Each Time Point
Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline).
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. At Cycle 4, Day 28, median and/or standard deviation were not able to be estimated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point | Cycle 1, Day 28 (n=34) | 0.83 ratio | Standard Deviation 0.222 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point | Cycle 2, Day 1 (n=29) | 0.89 ratio | Standard Deviation 0.287 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point | Cycle 2, Day 28 (n=22) | 0.77 ratio | Standard Deviation 0.246 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point | Cycle 3, Day 1 (n=16) | 0.81 ratio | Standard Deviation 0.224 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point | Cycle 3, Day 28 (n=8) | 0.69 ratio | Standard Deviation 0.126 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point | Cycle 5, Day 28 (n=3) | 0.76 ratio | Standard Deviation 0.354 |
Secondary
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Median soluble E-selectin concentration at each time point divided by median soluble E-selectin concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 6 weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 4, Day 28 and Cycle 5, Day 28.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 28 (CR or PR or SD, n=10) | 0.84 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 28 (PD, n=16) | 0.84 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 1 (CR or PR or SD, n=13) | 0.84 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 1 (PD, n=12) | 0.76 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 28 (CR or PR or SD, n=10) | 0.86 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 28 (PD, n=10) | 0.64 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 1 (CR or PR or SD, n=10) | 0.74 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 1 (PD, n=5) | 0.77 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 28 (CR or PR or SD, n=7) | 0.67 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 28 (PD, n=1) | 0.78 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 4, Day 28 (CR or PR or SD, n=1) | 1.13 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 5, Day 28 (CR or PR or SD, n=3) | 0.64 ratio |
Comparison: Cycle 1, Day 28p-value: 0.813Wilcoxon Rank Sum Test
Comparison: Cycle 2, Day 1p-value: 0.849Wilcoxon Rank Sum Test
Comparison: Cycle 2, Day 28p-value: 0.121Wilcoxon Rank Sum Test
Comparison: Cycle 3, Day 1p-value: 0.582Wilcoxon Rank Sum Test
Comparison: Cycle 3, Day 28p-value: 0.383Wilcoxon Rank Sum Test
Secondary
Time to Tumor Progression (TTP)
TTP was defined as the time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.
Time frame: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Time to Tumor Progression (TTP) | 23.6 weeks |
Secondary
Trough Plasma Concentration (Ctrough) of Sunitinib
Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.
Time frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Population: Pharmacokinetic (PK) = all subjects enrolled in the study who received at least 1 dose of carboplatin/paclitaxel or sunitinib. Subjects with plasma values below limit of quantification were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Trough Plasma Concentration (Ctrough) of Sunitinib | Cycle 1, Day 28 (n=51) | 57.69 nanograms (ng)/milliliter (mL) | Standard Deviation 29.37 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Trough Plasma Concentration (Ctrough) of Sunitinib | Cycle 2, Day 28 (n=36) | 50.88 nanograms (ng)/milliliter (mL) | Standard Deviation 33.67 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Trough Plasma Concentration (Ctrough) of Sunitinib | Cycle 3, Day 28 (n=16) | 41.55 nanograms (ng)/milliliter (mL) | Standard Deviation 24.28 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Trough Plasma Concentration (Ctrough) of Sunitinib | Cycle 5, Day 28 (n=6) | 38.57 nanograms (ng)/milliliter (mL) | Standard Deviation 21.83 |
Secondary
Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline
Concentration of VEGFR3 at baseline.
Time frame: Baseline (Cycle 1, Day 1) of Part 2
Population: Modified ITT population (MITT) = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin and at least 1 dose of Sunitinib.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline | 30382.83 picograms (pg)/milliliter (mL) | Standard Deviation 19134.12 |
Secondary
VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Median concentration of VEGF-C at baseline stratified by tumor response (CR or PR or \[SD \> = 6 Weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).
Time frame: Baseline (Cycle 1, Day 1) of Part 2
Population: MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 1 (CR or PR or SD, n=20) | 704.80 pg/mL |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 1 (PD, n=24) | 766.45 pg/mL |
p-value: 0.305Wilcoxon Rank Sum Test
Secondary
VEGF-C Concentration at Baseline
Concentration of VEGF-C at baseline.
Time frame: Baseline (Cycle 1, Day 1) of Part 2
Population: MITT. Number of participants analyzed = number of subjects with VEGF-C data at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Concentration at Baseline | 793.19 pg/mL | Standard Deviation 323.77 |
Secondary
VEGF-C Ratio to Baseline at Each Time Point
VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point | Cycle 1, Day 28 (n=46) | 0.81 ratio | Standard Deviation 0.342 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point | Cycle 2, Day 1 (n=39) | 0.90 ratio | Standard Deviation 0.396 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point | Cycle 2, Day 28 (n=30) | 0.91 ratio | Standard Deviation 0.577 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point | Cycle 3, Day 1 (n=20) | 1.00 ratio | Standard Deviation 0.46 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point | Cycle 3, Day 28 (n=12) | 0.91 ratio | Standard Deviation 0.34 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point | Cycle 5, Day 28 (n=4) | 0.89 ratio | Standard Deviation 0.269 |
Secondary
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Median VEGF-C concentration at each time point divided by median VEGF-C concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 6 weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 28 (CR or PR or SD, n=16) | 0.73 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 28 (PD, n=20) | 0.81 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 1 (CR or PR or SD, n=18) | 0.87 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 1 (PD, n=16) | 0.85 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 28 (CR or PR or SD, n=16) | 0.89 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 28 (PD, n=12) | 0.69 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 1 (CR or PR or SD, n=14) | 0.89 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 1 (PD, n=5) | 0.78 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 28 (CR or PR or SD, n=11) | 0.85 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 28 (PD, n=1) | 0.90 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 5, Day 28 (CR or PR or SD, n=4) | 0.78 ratio |
Comparison: Cycle 1, Day 28p-value: 0.738Wilcoxon Rank Sum Test
Comparison: Cycle 2, Day 1p-value: 0.438Wilcoxon Rank Sum Test
Comparison: Cycle 2, Day 28p-value: 0.236Wilcoxon Rank Sum Test
Comparison: Cycle 3, Day 1p-value: 0.287Wilcoxon Rank Sum Test
Comparison: Cycle 3, Day 28p-value: 0.772Wilcoxon Rank Sum Test
Secondary
VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Median concentration of VEGFR3 at baseline stratified by tumor response (CR or PR or \[SD \> = 6 Weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).
Time frame: Baseline (Cycle 1, Day 1) of Part 2
Population: MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 1 (CR or PR or SD, n=21) | 21660.00 pg/mL |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 1 (PD, n=24) | 27740.00 pg/mL |
p-value: 0.474Wilcoxon Rank Sum Test
Secondary
VEGFR3 Ratio to Baseline at Each Time Point
VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline).
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point | Cycle 1, Day 28 (n=46) | 0.39 ratio | Standard Deviation 0.201 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point | Cycle 2, Day 1 (n=40) | 0.74 ratio | Standard Deviation 0.255 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point | Cycle 2, Day 28 (n=29) | 0.36 ratio | Standard Deviation 0.165 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point | Cycle 3, Day 1 (n=21) | 0.70 ratio | Standard Deviation 0.288 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point | Cycle 3, Day 28 (n=12) | 0.31 ratio | Standard Deviation 0.111 |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point | Cycle 5, Day 28 (n=4) | 0.31 ratio | Standard Deviation 0.163 |
Secondary
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Median VEGFR3 concentration at each time point divided by median VEGFR3 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 6 weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Time frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Population: MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 28 (CR or PR or SD, n=16) | 0.34 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 1, Day 28 (PD, n=20) | 0.35 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 1 (CR or PR or SD, n=19) | 0.75 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 1 (PD, n=16) | 0.84 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 28 (CR or PR or SD, n=15) | 0.32 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 2, Day 28 (PD, n=12) | 0.38 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 1 (CR or PR or SD, n=15) | 0.57 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 1 (PD, n=5) | 0.92 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 28 (CR or PR or SD, n=11) | 0.38 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 3, Day 28 (pd, n=1) | 0.43 ratio |
| First Carboplatin Plus Paclitaxel, Then Sunitinib | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Cycle 5, Day 28 (CR or PR or SD, n=4) | 0.30 ratio |
Comparison: Cycle 1, Day 28p-value: 0.836Wilcoxon Rank Sum Test
Comparison: Cycle 2, Day 1p-value: 0.071Wilcoxon Rank Sum Test
Comparison: Cycle 2, Day 28p-value: 0.393Wilcoxon Rank Sum Test
Comparison: Cycle 3, Day 1p-value: 0.029Wilcoxon Rank Sum Test
Comparison: Cycle 3, Day 28p-value: 0.247Wilcoxon Rank Sum Test