Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
- Conditions
- Ovarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00005026
- 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.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer.
- Detailed Description
OBJECTIVES: I. Determine the feasibility of administering multiple courses of carboplatin and topotecan without excessive dose modification or course delay in patients with previously untreated ovarian epithelial or primary peritoneal carcinoma. II. Describe the response rate and progression-free interval in these patients with this treatment regimen. III. Determine pharmacokinetic and pharmacodynamic parameters related to the sequence of carboplatin and topotecan administration in these patients.
OUTLINE: Patients are assigned to one of three treatment regimens. Regimen I: Patients receive carboplatin IV over 30 minutes on day 1 followed by topotecan IV over 30 minutes on days 1-3. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen II: Patients receive topotecan IV over 30 minutes on days 1-3 followed by carboplatin IV over 30 minutes on day 3. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen III: Patients receive topotecan IV over 30 minutes on days 1-5 followed by carboplatin IV over 30 minutes on day 5. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 15-80 patients will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
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 (47)
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Ellis Fischel Cancer Center
🇺🇸Columbia, Missouri, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, New Jersey, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Community Hospital of Los Gatos
🇺🇸Los Gatos, California, United States
Tampa Bay Cancer Consortium
🇺🇸Saint Petersburg, Florida, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Radiation Oncology Branch
🇺🇸Bethesda, Maryland, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States