Gemcitabine in Ovarian Cancer
- Registration Number
- NCT00191334
- Lead Sponsor
- Eli Lilly and Company
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- ECOG = 0-2
- Operated patients
- disease stage III-IV
- No prior chemotherapy or radiation therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A cisplatin - A gemcitabine -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇷🇺Stavropol, Russian Federation