Paclitaxel and Cisplatin in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
- Conditions
- Ovarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00002717
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for ovarian or peritoneal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of paclitaxel plus cisplatin in treating patients who have residual disease after surgery to remove stage III or stage IV ovarian cancer or primary peritoneal cancer.
- Detailed Description
OBJECTIVES: I. Compare progression free and overall survival and frequency of response in patients with suboptimal stage III or IV ovarian epithelial cancer or primary peritoneal cancer treated with a 24 hour vs 96 hour infusion of paclitaxel (TAX) followed by cisplatin. II. Determine the incidence and severity of adverse events, including catheter complications and drug toxicity, for the 96 hour infusion of TAX. III. Compare the relationship between plasma TAX concentrations, toxicity, and response to both infusion schedules in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and measurable disease (yes vs no). Patients are randomized into one of two treatment arms. Arm I: Patients receive paclitaxel IV continuously over 24 hours followed by cisplatin IV over 2 hours. Arm II: Patients receive paclitaxel IV continuously over 96 hours followed by cisplatin IV over 2 hours. Treatment repeats every 3 weeks for 6 courses.
PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study over 4.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 324
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (52)
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Women's Cancer Center
🇺🇸Palo Alto, California, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Scroll for more (42 remaining)University of Alabama Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States