Breast Cancer
Conditions
Brief summary
The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer
Interventions
DRUGcisplatin
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
DRUGGemcitabine
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* You are female in the age of 18 to 75 years old. * You have been diagnosed with the metastatic breast cancer. * You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up. * You must sign this informed consent form
Exclusion criteria
* You are pregnant or breastfeeding. * Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study. * You have been diagnosed with serious concomitant or acute infectious disease. * You have used experimental medications within the last month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Tumor Response | baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.) | Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progressive Disease | first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) | Defined as the time from study enrollment to the first date of disease progression. |
| Time to Treatment Failure | first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) | Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. |
| Survival Time | first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) | Overall survival is the duration from enrollment to death due to any cause. |
| Duration of Response | first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. |
| Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) | Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death). |
| Number of Deaths | Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) | — |
| Number of Participants With Adverse Events Leading to Discontinuation | Baseline through eight 21-day cycles | — |
| Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) | The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). |
Countries
Germany, Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine + Cisplatin Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle). | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 2 |
| Overall Study | Disease progression or relapse | 24 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Gemcitabine + Cisplatin |
|---|---|
| Age Continuous | 50.5 years STANDARD_DEVIATION 9.7 |
| Menopausal Status Post-menopausal | 54 participants |
| Menopausal Status Pre-menopausal | 16 participants |
| Pathological Diagnosis Adenocystic breast carcinoma | 10 participants |
| Pathological Diagnosis Ductal and lobular breast carcinoma | 2 participants |
| Pathological Diagnosis Ductal breast carcinoma | 44 participants |
| Pathological Diagnosis Lobular breast carcinoma | 5 participants |
| Pathological Diagnosis Mucinous breast carcinoma | 1 participants |
| Pathological Diagnosis Papillary carcinoma | 1 participants |
| Pathological Diagnosis Unknown | 7 participants |
| Region of Enrollment Germany | 7 participants |
| Region of Enrollment Russian Federation | 63 participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 0 Participants |
| Stage of Disease at Entry to the Study Stage IIIb | 1 participants |
| Stage of Disease at Entry to the Study Stage IV | 69 participants |
| Stage of Disease at Time of Diagnosis Stage I | 3 participants |
| Stage of Disease at Time of Diagnosis Stage IIa | 13 participants |
| Stage of Disease at Time of Diagnosis Stage IIb | 22 participants |
| Stage of Disease at Time of Diagnosis Stage IIIa | 12 participants |
| Stage of Disease at Time of Diagnosis Stage IIIb | 15 participants |
| Stage of Disease at Time of Diagnosis Stage IV | 5 participants |
| Time from Initial Diagnosis to Study Entry | 37.6 month STANDARD_DEVIATION 39.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 54 / — |
| serious Total, serious adverse events | 6 / — |
Outcome results
Primary
Objective Tumor Response
Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.
Time frame: baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)
Population: Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Objective Tumor Response | Partial Response | 19 participants |
| Gemcitabine + Cisplatin | Objective Tumor Response | Stable Disease | 19 participants |
| Gemcitabine + Cisplatin | Objective Tumor Response | Complete Response | 7 participants |
| Gemcitabine + Cisplatin | Objective Tumor Response | Progressive Disease | 5 participants |
| Gemcitabine + Cisplatin | Objective Tumor Response | Not Assessable | 4 participants |
Secondary
Duration of Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time frame: first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Population: Response population: all enrolled participants who had either a complete or partial response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine + Cisplatin | Duration of Response | 32.7 weeks |
Secondary
Number of Deaths
Time frame: Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Number of Deaths | Disease Progression | 35 participants |
| Gemcitabine + Cisplatin | Number of Deaths | Ventricular Fibrillation | 1 participants |
| Gemcitabine + Cisplatin | Number of Deaths | Circulatory Arrest | 1 participants |
Secondary
Number of Participants With Adverse Events Leading to Discontinuation
Time frame: Baseline through eight 21-day cycles
Population: Safety Population: all enrolled participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Number of Participants With Adverse Events Leading to Discontinuation | Patients with >=1 AE leading to discontinuation | 2 participants |
| Gemcitabine + Cisplatin | Number of Participants With Adverse Events Leading to Discontinuation | Pneumonia | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Adverse Events Leading to Discontinuation | Toxic skin eruption | 1 participants |
Secondary
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death).
Time frame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
Population: Safety Population: all enrolled participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Hemoglobin (g/L) - Grade 1 | 35 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Hemoglobin (g/L) - Grade 2 | 20 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Hemoglobin (g/L) - Grade 3 | 5 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Hemoglobin (g/L) - Grade 4 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Neutrophils (x10E9/L) - Grade 1 | 6 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Neutrophils (x10E9/L) - Grade 2 | 25 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Neutrophils (x10E9/L) - Grade 3 | 13 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Neutrophils (x10E9/L) - Grade 4 | 10 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Platelets (x10E9/L) - Grade 1 | 43 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Platelets (x10E9/L) - Grade 2 | 2 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Platelets (x10E9/L) - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Platelets (x10E9/L) - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | White Blood Cells (x10E9/L) - Grade 1 | 16 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | White Blood Cells (x10E9/L) - Grade 2 | 27 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | White Blood Cells (x10E9/L) - Grade 3 | 18 participants |
| Gemcitabine + Cisplatin | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | White Blood Cells (x10E9/L) - Grade 4 | 3 participants |
Secondary
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).
Time frame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
Population: Safety Population: all enrolled participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Other auditory/hearing - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Rigors, chills - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Rigors, chills - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Allergic reaction/hypersensivity - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Allergic reaction/hypersensivity - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Allergic reaction/hypersensivity - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Allergic reaction/hypersensivity - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Allergic rhinitis - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Allergic rhinitis - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Allergic rhinitis - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Allergic rhinitis - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Other auditory/hearing - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Other auditory/hearing - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Other auditory/hearing - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Blood/Bone marrow - other - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Blood/Bone marrow - other - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Blood/Bone marrow - other - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Blood/Bone marrow - other - Grade 4 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Cardiac- ischemia/infarction - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Cardiac- ischemia/infarction - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Cardiac- ischemia/infarction - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Cardiac- ischemia/infarction - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Hypertension - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Hypertension - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Hypertension - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Hypertension - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Hypotension - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Hypotension - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Hypotension - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Hypotension - Grade 4 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Fatigue - Grade 1 | 6 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Fatigue - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Fatigue - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Fatigue - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Fever - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Fever - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Fever - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Fever - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Rigors, chills - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Rigors, chills - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Weight loss - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Weight loss - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Weight loss - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Weight loss - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Alopecia - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Alopecia - Grade 2 | 3 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Alopecia - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Alopecia - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Rash/desquamation - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Rash/desquamation - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Rash/desquamation - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Rash/desquamation - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Anorexia - Grade 1 | 4 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Anorexia - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Anorexia - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Anorexia - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Constipation - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Constipation - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Constipation - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Constipation - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Mucositis due to radiation - Grade 1 | 2 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Mucositis due to radiation - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Mucositis due to radiation - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Mucositis due to radiation - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Nausea - Grade 1 | 10 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Nausea - Grade 2 | 8 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Nausea - Grade 3 | 2 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Nausea - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Vomiting - Grade 1 | 4 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Vomiting - Grade 2 | 7 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Vomiting - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Vomiting - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | SGPT (ALT) - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | SGPT (ALT) - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | SGPT (ALT) - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | SGPT (ALT) - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Infection without neutropenia - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Infection without neutropenia - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Infection without neutropenia - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Infection without neutropenia - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Insomnia - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Insomnia - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Insomnia - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Insomnia - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Abdominal pain or cramping - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Abdominal pain or cramping - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Abdominal pain or cramping - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Abdominal pain or cramping - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Headache - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Headache - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Headache - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Headache - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Pain - Other - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Pain - Other - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Pain - Other - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Pain - Other - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Renal/Genitourinary - Other - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Renal/Genitourinary - Other - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Renal/Genitourinary - Other - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | Renal/Genitourinary - Other - Grade 4 | 0 participants |
Secondary
Survival Time
Overall survival is the duration from enrollment to death due to any cause.
Time frame: first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Population: Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine + Cisplatin | Survival Time | 84.0 weeks |
Secondary
Time to Progressive Disease
Defined as the time from study enrollment to the first date of disease progression.
Time frame: first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Population: Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine + Cisplatin | Time to Progressive Disease | 33.9 weeks |
Secondary
Time to Treatment Failure
Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment.
Time frame: first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Population: Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine + Cisplatin | Time to Treatment Failure | 26.2 weeks |