Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
- Conditions
- Ovarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00086892
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Combining cetuximab with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal cancer.
- Detailed Description
OBJECTIVES:
* Determine the antitumor activity of cetuximab and carboplatin in patients with recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.
* Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8 , and 15. Patients also receive carboplatin IV after cetuximab administration on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 20-65 patients will be accrued for this study.
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 (75)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Fox Chase-Temple Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Gynecologic Oncology Network
🇺🇸Greenville, North Carolina, United States
Australia New Zealand Gynaecological Oncology Trials Group
🇦🇺Camperdown, New South Wales, Australia
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Women's Cancer Center - Los Gatos
🇺🇸Los Gatos, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Long Island Cancer Center at Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Southeast Gynecologic Oncology Associates
🇺🇸Knoxville, Tennessee, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
Keesler Medical Center - Keesler Air Force Base
🇺🇸Keesler AFB, Mississippi, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
🇺🇸Camden, New Jersey, United States
Kagoshima City Hospital
🇯🇵Kagoshima City, Japan
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Norwegian Radium Hospital
🇳🇴Oslo, Norway
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Tom Baker Cancer Centre - Calgary
🇨🇦Calgary, Alberta, Canada
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
🇺🇸Burlington, Vermont, United States
Yale Comprehensive Cancer Center at Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States