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)
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
Women's Cancer Center
🇺🇸Palo Alto, California, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Center, University of Virginia HSC
🇺🇸Charlottesville, Virginia, United States
CCOP - Baptist Cancer Institute
🇺🇸Memphis, Tennessee, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, New Jersey, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, 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
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States