Ovarian Cancer
Conditions
Brief summary
The primary endpoint of this study is to assess the objective tumor response rate in patients with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250 mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment
Interventions
DRUGgemcitabine
1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity
DRUGcisplatin
75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity
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 No maximum
Healthy volunteers
No
Inclusion criteria
* ECOG = 0-2 * Operated patients * disease stage III-IV
Exclusion criteria
* No prior chemotherapy or radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Tumor Response | every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up | Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response | every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up | 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 to Progressive Disease | every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. |
| Time to Treatment Failure | every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up | 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 to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. |
| Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up | Grades range from 0 (no toxicity) to 4 (life-threatening or disabling). |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine + Cisplatin Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Disease Progression or Relapse | 8 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Gemcitabine + Cisplatin |
|---|---|
| Age Continuous | 54.9 years STANDARD_DEVIATION 10.7 |
| Disease Stage Stage IIIa - Microscopic Peritoneal Metastasis | 1 participants |
| Disease Stage Stage IIIb - Macroscopic Peritoneal Metastasis | 3 participants |
| Disease Stage Stage IIIc - Peritoneal Metastasis More Than 2 cm | 21 participants |
| Disease Stage Stage II - Pelvic Extension and/or Implants | 0 participants |
| Disease Stage Stage I - Tumor Limited to Ovaries | 0 participants |
| Disease Stage Stage IV - Distant Metastases | 25 participants |
| Eastern Cooperative Oncology Group Performance Status Score 0 - Fully Active | 28 participants |
| Eastern Cooperative Oncology Group Performance Status Score 1 - Ambulatory, Restricted Strenuous Activity | 20 participants |
| Eastern Cooperative Oncology Group Performance Status Score 2 - Ambulatory, No Work Activities | 2 participants |
| Eastern Cooperative Oncology Group Performance Status Score 3 - Partially Confined to Bed, Limited Self Care | 0 participants |
| Eastern Cooperative Oncology Group Performance Status Score 4 - Completely Disabled | 0 participants |
| Postoperational Pathomorphological Diagnosis Endometrioid Carcinoma | 4 participants |
| Postoperational Pathomorphological Diagnosis Mucinosa Cystadenocarcinoma | 3 participants |
| Postoperational Pathomorphological Diagnosis Other | 6 participants |
| Postoperational Pathomorphological Diagnosis Serous Cystadenocarcinoma | 37 participants |
| Race/Ethnicity Caucasian | 49 participants |
| Race/Ethnicity Other | 1 participants |
| Region of Enrollment Russian Federation | 50 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
| State of Patient Relative to Menopause Fertile Period | 4 participants |
| State of Patient Relative to Menopause Post-Menopause | 46 participants |
| Time from Initial Diagnosis to Study Entry | 14.0 days STANDARD_DEVIATION 10.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 48 / — |
| serious Total, serious adverse events | 2 / — |
Outcome results
Primary
Best Overall Tumor Response
Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Time frame: every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Best Overall Tumor Response | Complete Response | 6 participants |
| Gemcitabine + Cisplatin | Best Overall Tumor Response | Partial Response | 25 participants |
| Gemcitabine + Cisplatin | Best Overall Tumor Response | Stable Disease | 10 participants |
| Gemcitabine + Cisplatin | Best Overall Tumor Response | Progressive Disease | 5 participants |
| Gemcitabine + Cisplatin | Best Overall Tumor Response | Not Assessed | 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: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine + Cisplatin | Duration of Response | 37.0 weeks |
Secondary
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Grades range from 0 (no toxicity) to 4 (life-threatening or disabling).
Time frame: every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Renal failure - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Patients with at least one CTC - Grade 1 | 34 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Patients with at least one CTC - Grade 2 | 6 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Patients with at least one CTC - Grade 3 | 2 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Patients with at least one CTC - Grade 4 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Other auditory/hearing - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Other auditory/hearing - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Other auditory/hearing - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Other auditory/hearing - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Leukocytes - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Leukocytes - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Leukocytes - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Leukocytes - Grade 4 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Neutrophils/granulocytes - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Neutrophils/granulocytes - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Neutrophils/granulocytes - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Neutrophils/granulocytes - Grade 4 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Fatigue - Grade 1 | 11 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Fatigue - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Fatigue - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Fatigue - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Weight loss - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Weight loss - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Weight loss - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Weight loss - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Alopecia - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Alopecia - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Alopecia - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Alopecia - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Rash/desquamation - Grade 1 | 2 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Rash/desquamation - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Rash/desquamation - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Rash/desquamation - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Anorexia - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Anorexia - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Anorexia - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Anorexia - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Diarrhea (without colostomy) - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Diarrhea (without colostomy) - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Diarrhea (without colostomy) - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Diarrhea (without colostomy) - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Nausea - Grade 1 | 29 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Nausea - Grade 2 | 2 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Nausea - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Nausea - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Other Gastrointestinal - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Other Gastrointestinal - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Other Gastrointestinal - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Other Gastrointestinal - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Stomatitis/pharyngitis - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Stomatitis/pharyngitis - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Stomatitis/pharyngitis - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Stomatitis/pharyngitis - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Vomiting - Grade 1 | 24 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Vomiting - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Vomiting - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Vomiting - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Alkaline phosphatase - Grade 1 | 13 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Alkaline phosphatase - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Alkaline phosphatase - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Alkaline phosphatase - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Bilirubin - Grade 1 | 6 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Bilirubin - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Bilirubin - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Bilirubin - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Serum glutamic oxaloacetic transaminase - Grade 1 | 8 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Serum glutamic oxaloacetic transaminase - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Serum glutamic oxaloacetic transaminase - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Serum glutamic oxaloacetic transaminase - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Serum glutamic pyruvic transaminase - Grade 1 | 7 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Serum glutamic pyruvic transaminase - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Serum glutamic pyruvic transaminase - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Serum glutamic pyruvic transaminase - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Dizziness/lightheadedness - Grade 1 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Dizziness/lightheadedness - Grade 2 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Dizziness/lightheadedness - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Dizziness/lightheadedness - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Headache - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Headache - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Headache - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Headache - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Creatinine - Grade 1 | 7 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Creatinine - Grade 2 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Creatinine - Grade 3 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Creatinine - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Renal failure - Grade 1 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Renal failure - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Renal failure - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Renal/genitourinary - Other - Grade 1 | 6 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Renal/genitourinary - Other - Grade 2 | 2 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Renal/genitourinary - Other - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Renal/genitourinary - Other - Grade 4 | 0 participants |
Secondary
Time to Progressive Disease
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Time frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine + Cisplatin | Time to Progressive Disease | 45.1 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 to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Time frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine + Cisplatin | Time to Treatment Failure | 38.4 weeks |