Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer
- Conditions
- Ovarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00003322
- 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 and giving drugs in different ways may kill more tumor cells. It is not yet known whether intravenous two-drug combination chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous two-drug combination chemotherapy with intravenous and intraperitoneal three-drug combination chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian cancer.
- Detailed Description
OBJECTIVES: I. Compare pathological response, recurrence-free interval, and survival in patients with optimal stage III epithelial ovarian cancer or primary peritoneal carcinoma receiving intravenous (IV) paclitaxel and cisplatin vs IV paclitaxel and intraperitoneal (IP) cisplatin plus IP paclitaxel. II. Compare the toxic effects and complications of these 2 treatment regimens in these patients. III. Determine the frequency and prognostic significance of BRCA1 and BRCA2 mutations in these patients. IV. Determine the effect of non-genetic risk factors on the course of disease in BRCA1- and BRCA2-related ovarian cancer or primary peritoneal carcinoma. V. Compare the quality of life of these patients receiving these treatments.
OUTLINE: This is a randomized study. Patients are stratified according to gross residual disease (present vs absent) and whether second-look surgery will be performed at the end of treatment (yes vs no). Blood is drawn for BRCA mutation analysis and DNA extraction before the start of chemotherapy, but after randomization. Patients are randomized to one of two treatment arms. Patients in arm I receive IV paclitaxel by 24-hour infusion on day 1 followed by IV cisplatin on day 2. Patients in arm II receive IV paclitaxel by 24-hour infusion on day 1 followed by intraperitoneal (IP) cisplatin on day 2, plus IP paclitaxel on day 8. Treatment for both arms repeats every 3 weeks for a total of 6 treatment courses. Following chemotherapy, second look surgery is performed if selected by the patient. Quality-of-life assessments are performed prior to randomization, prior to course 4, 3-6 weeks after the completion of course 6 and prior to second look surgery if selected, 6 months after treatment is completed, and 12 months after treatment is completed. Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 384 patients will be accrued for this study within 16 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 384
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 (67)
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Lombardi Cancer Center, Georgetown University
🇺🇸Washington, District of Columbia, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, New Jersey, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
CCOP - Baptist Cancer Institute
🇺🇸Memphis, Tennessee, United States
CCOP - Sooner State
🇺🇸Tulsa, Oklahoma, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Cancer Center, University of Virginia HSC
🇺🇸Charlottesville, Virginia, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Women's Cancer Center
🇺🇸Palo Alto, California, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Medicine Branch
🇺🇸Bethesda, Maryland, United States
Radiation Oncology Branch
🇺🇸Bethesda, Maryland, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States