Lung Cancer, Non-Small Cell, Non-Small-Cell Lung Cancer
Conditions
Keywords
HYCAMTIN, TAXOTERE, non-small cell lung cancer, NSCLC, docetaxel, topotecan, Stage IIIB/IV, Advanced
Brief summary
The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.
Interventions
DRUGTopotecan/Docetaxel combination
DRUGDocetaxel
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * At least 18 years old * Confirmed advanced non-small cell lung carcinoma (NSCLC) * Received one prior chemotherapy for metastatic NSCLC excluding TAXOTERE or HYCAMTIN. In addition, subjects are allowed to have previously received a non-cytotoxic therapy, such as an endothelial growth factor receptor (EGFR) or angiogenesis inhibitor. * Presence of either measurable or non-measurable disease by radiologic study or physical examination. * Full recovery and at least 21 days from prior treatment for NSCLC; 42 days from treatment with mitomycin or nitrosureas and 30 days from prior non-cytotoxic therapy. * At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient). * At least 7 days since prior radiotherapy. * A probable life expectance of at least 3 months. * Adequate bone marrow reserve, CBC/Platelet, kidney and liver function.
Exclusion criteria
* Concomitant malignancies or other malignancies within the last five years. * Symptoms of brain metastases requiring treatment with steroids. * Active infection. * Severe medical problems other than the diagnosis of NSCLC that would limit the ability of the subject to follow study guidelines or expose the subject to extreme risk. * Ongoing or planned chemotherapy (other than treatment during this study), immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC. * Use of investigational drug within 30 days or 5 half-lives prior to the first dose of study medication. * Women who are pregnant or lactating. * Subjects of child-bearing potential refusing to practice adequate contraception. * Prior treatment with or history of allergic reaction to either HYCAMTIN or TAXOTERE. * Subjects who cannot receive steroid premedication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Time of Overall Survival | Up to one year from Day -1 (randomization) | Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Progression | Up to one year from Day -1 (randomization) | Time to progression is defined as the time between randomization and the first radiologically or clinically documented evidence of progression. |
| Response Rate | Up to one year from Day -1 (randomization) | Response rate is defined as the percentage of participants in the ITT population attaining an overall best response of complete or partial response. |
| Response Duration | Up to one year from Day -1 (randomization) | Response duration is defined as the time from initial radiologically documented response to the first radiologically or clinically documented sign of progression. |
| Time to Response-assessed Every 8 Weeks | Every 8 Weeks post randomization | Time to response is defined as the time between randomization and the first radiologically documented complete or partial response. |
| Number of Participants With One-year Survival | Up to one year from Day -1 (randomization) | Number of participants with one-year survival were planned to be reported. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 16 months | AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or it is considered to be medically significant. |
| Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Up to 16 months | Hematology parameters included hemoglobin, hematocrit, red blood cell count, white blood cell count with differential leukocyte and platelet count. Differential to include total neutrophils, bands, lymphocytes, monocytes, eosinophil, and basophils. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 1, 2, 3 or 4 hematologic toxicities have been presented. |
| Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Up to 16 months | Standard chemistry evaluation included sodium, potassium, chloride, bicarbonate, calcium, phosphorous, magnesium, blood urea nitrogen (BUN)/urea, uric acid, creatinine, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, total protein and albumin. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 3 or 4 clinical chemical toxicities have been presented. |
| Number of Participants With Clinically Significant Abnormal Vital Signs Data | Up to 16 months | Vital sign parameters included (blood pressure, and pulse rate after five minutes sitting, body temperature). Blood pressure and pulse rate was measured after sitting for 5 minutes. Only participants with clinically significant abnormal Vital sign data was reported. |
| Assessment of Quality of Life-assessed Every 4 Weeks | Every 4 Weeks post randomization | The effect of treatment regimens on participants-perceived disease status and well-being was assessed using Lung Cancer Symptom Scale (LCSS) that consists of 9 items addressing the time frame of past day: 6 measuring major symptoms for lung malignancies (loss of appetite, fatigue, cough, dyspnea, hemoptysis and pain) and 3 summation items related to total symptomatic distress, activity status and global quality of life. All items are measured by visual analogue scales (VAS) which uses 100 millimeter (mm) lines to determine the intensity of participant responses. The lowest level of symptom intensity or functional disability on the VAS is on left (none) and highest intensity is on right (as much as could be). |
Countries
Canada, Poland, United States
Participant flow
Recruitment details
This was a multicenter study conducted at 62 centers: 11 in Canada, 5 in Poland, and 46 in the United States from 14 August 2003 to 30 August 2007. A total of 399 participants with advanced non-small cell lung cancer (NSCLC) were enrolled in the study and randomized to treatment.
Pre-assignment details
Based on the interim analysis results, the independent data monitoring committee (IDMC) recommended termination of the combination group due to increased toxicity as well as a low likelihood of demonstrating an overall survival benefit at the final analysis.
Participants by arm
| Arm | Count |
|---|---|
| IV Topotecan + IV Docetaxel Eligible participants received IV topotecan 3.5 mg/m\^2/day and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study. | 202 |
| IV Docetaxel Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study. | 197 |
| Total | 399 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 24 | 17 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Decline in Status | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 4 |
| Overall Study | No clinical benefit | 1 | 0 |
| Overall Study | Protocol Violation | 3 | 4 |
| Overall Study | Serious adverse events (SAE) | 1 | 0 |
| Overall Study | Sponsor Decision | 11 | 7 |
| Overall Study | Withdrawal by Subject | 8 | 3 |
Baseline characteristics
| Characteristic | IV Topotecan + IV Docetaxel | IV Docetaxel | Total |
|---|---|---|---|
| Age, Customized 18-40 | 4 Participants | 1 Participants | 5 Participants |
| Age, Customized 41-64 | 129 Participants | 116 Participants | 245 Participants |
| Age, Customized >=65 | 69 Participants | 80 Participants | 149 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 13 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 184 Participants | 183 Participants | 367 Participants |
| Sex: Female, Male Female | 63 Participants | 78 Participants | 141 Participants |
| Sex: Female, Male Male | 139 Participants | 119 Participants | 258 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 170 / 200 | 165 / 195 |
| other Total, other adverse events | 181 / 200 | 166 / 195 |
| serious Total, serious adverse events | 58 / 200 | 49 / 195 |
Outcome results
Primary
Median Time of Overall Survival
Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment.
Time frame: Up to one year from Day -1 (randomization)
Population: Intent-to-treat (ITT) population was defined as all participants randomized to one of the two treatment regimens.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Topotecan + IV Docetaxel | Median Time of Overall Survival | 30.7 Weeks |
| IV Docetaxel | Median Time of Overall Survival | 28.6 Weeks |
p-value: 0.94695% CI: [0.813, 1.248]Log Rank
95% CI: [0.788, 1.21]
Secondary
Assessment of Quality of Life-assessed Every 4 Weeks
The effect of treatment regimens on participants-perceived disease status and well-being was assessed using Lung Cancer Symptom Scale (LCSS) that consists of 9 items addressing the time frame of past day: 6 measuring major symptoms for lung malignancies (loss of appetite, fatigue, cough, dyspnea, hemoptysis and pain) and 3 summation items related to total symptomatic distress, activity status and global quality of life. All items are measured by visual analogue scales (VAS) which uses 100 millimeter (mm) lines to determine the intensity of participant responses. The lowest level of symptom intensity or functional disability on the VAS is on left (none) and highest intensity is on right (as much as could be).
Time frame: Every 4 Weeks post randomization
Population: ITT population. Data was not collected for this outcome measure.
Secondary
Median Time to Progression
Time to progression is defined as the time between randomization and the first radiologically or clinically documented evidence of progression.
Time frame: Up to one year from Day -1 (randomization)
Population: ITT population. Data was not collected for this outcome measure.
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or it is considered to be medically significant.
Time frame: Up to 16 months
Population: mITT Population was defined as all participants who were randomized and received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Topotecan + IV Docetaxel | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 186 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 58 Participants |
| IV Docetaxel | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 172 Participants |
| IV Docetaxel | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 49 Participants |
Secondary
Number of Participants With Clinically Significant Abnormal Vital Signs Data
Vital sign parameters included (blood pressure, and pulse rate after five minutes sitting, body temperature). Blood pressure and pulse rate was measured after sitting for 5 minutes. Only participants with clinically significant abnormal Vital sign data was reported.
Time frame: Up to 16 months
Population: mITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Topotecan + IV Docetaxel | Number of Participants With Clinically Significant Abnormal Vital Signs Data | 0 Participants |
| IV Docetaxel | Number of Participants With Clinically Significant Abnormal Vital Signs Data | 0 Participants |
Secondary
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Hematology parameters included hemoglobin, hematocrit, red blood cell count, white blood cell count with differential leukocyte and platelet count. Differential to include total neutrophils, bands, lymphocytes, monocytes, eosinophil, and basophils. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 1, 2, 3 or 4 hematologic toxicities have been presented.
Time frame: Up to 16 months
Population: mITT population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Neutrophils, Grade 2 | 37 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Platelets, Grade 2 | 20 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Hemoglobin, Grade 2 | 95 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Platelets, Grade 3 | 18 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Neutrophils, Grade 3 | 47 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Platelets, Grade 4 | 1 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Neutrophils, Grade 1 | 27 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | White blood cell, Grade 1 | 38 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Neutrophils, Grade 4 | 20 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | White blood cell, Grade 2 | 51 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Hemoglobin, Grade 3 | 18 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | White blood cell, Grade 3 | 50 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Platelets, Grade 1 | 75 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | White blood cell, Grade 4 | 15 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Hemoglobin, Grade 1 | 76 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | White blood cell, Grade 4 | 2 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Hemoglobin, Grade 1 | 107 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Hemoglobin, Grade 2 | 46 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Hemoglobin, Grade 3 | 11 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Neutrophils, Grade 1 | 14 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Neutrophils, Grade 2 | 7 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Neutrophils, Grade 3 | 7 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Neutrophils, Grade 4 | 11 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Platelets, Grade 1 | 10 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Platelets, Grade 2 | 3 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Platelets, Grade 3 | 0 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Platelets, Grade 4 | 0 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | White blood cell, Grade 1 | 28 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | White blood cell, Grade 2 | 14 Participants |
| IV Docetaxel | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | White blood cell, Grade 3 | 13 Participants |
Secondary
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Standard chemistry evaluation included sodium, potassium, chloride, bicarbonate, calcium, phosphorous, magnesium, blood urea nitrogen (BUN)/urea, uric acid, creatinine, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, total protein and albumin. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 3 or 4 clinical chemical toxicities have been presented.
Time frame: Up to 16 months
Population: mITT population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Albumin, Grade 3 | 3 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Bilirubin, Grade 3 | 1 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | AST, Grade 3 | 0 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Sodium, Grade 3 | 12 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Creatinine, Grade 3 | 0 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | AST, Grade 4 | 1 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Calcium, Grade 3 | 2 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | BUN/Urea, Grade 3 | 4 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Calcium, Grade 4 | 0 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | ALT, Grade 3 | 1 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Potassium, Grade 3 | 7 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Alkaline Phosphatase, Grade 3 | 1 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Potassium, Grade 4 | 1 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | ALT, Grade 4 | 1 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Magnesium, Grade 3 | 4 Participants |
| IV Topotecan + IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Sodium, Grade 4 | 0 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Magnesium, Grade 3 | 2 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Albumin, Grade 3 | 3 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | BUN/Urea, Grade 3 | 2 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Creatinine, Grade 3 | 1 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Alkaline Phosphatase, Grade 3 | 1 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | AST, Grade 3 | 1 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | AST, Grade 4 | 0 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | ALT, Grade 3 | 0 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | ALT, Grade 4 | 0 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Bilirubin, Grade 3 | 2 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Sodium, Grade 3 | 9 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Sodium, Grade 4 | 1 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Calcium, Grade 3 | 2 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Calcium, Grade 4 | 1 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Potassium, Grade 3 | 3 Participants |
| IV Docetaxel | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Potassium, Grade 4 | 1 Participants |
Secondary
Number of Participants With One-year Survival
Number of participants with one-year survival were planned to be reported.
Time frame: Up to one year from Day -1 (randomization)
Population: ITT population. Data was not collected for this outcome measure.
Secondary
Response Duration
Response duration is defined as the time from initial radiologically documented response to the first radiologically or clinically documented sign of progression.
Time frame: Up to one year from Day -1 (randomization)
Population: ITT population. Data was not collected for this outcome measure.
Secondary
Response Rate
Response rate is defined as the percentage of participants in the ITT population attaining an overall best response of complete or partial response.
Time frame: Up to one year from Day -1 (randomization)
Population: ITT population. Data was not collected for this outcome measure.
Secondary
Time to Response-assessed Every 8 Weeks
Time to response is defined as the time between randomization and the first radiologically documented complete or partial response.
Time frame: Every 8 Weeks post randomization
Population: ITT population. Data was not collected for this outcome measure.