Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
NCT ID: NCT00086892
Last Updated: 2014-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2004-06-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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cetuximab
carboplatin
Eligibility Criteria
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Inclusion Criteria
* Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* GOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No uncontrolled hypertension
* No unstable angina
* No congestive heart failure
* No uncontrolled arrhythmias within the past 6 months
* No other significant cardiac disease
Neurologic
* No uncontrolled seizure disorder
* No active neurological disease
* No neuropathy \> grade 1
Other
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No active infection requiring antibiotics
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior anti-epidermal growth factor receptor (EGFR) antibody therapy
* No prior chimerized or murine monoclonal antibody therapy
* At least 3 weeks since prior biologic or immunologic therapy for the malignancy
Chemotherapy
* See Disease Characteristics
* Recovered from prior chemotherapy
* No prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimens
Endocrine therapy
* At least 1 week since prior hormonal therapy for the malignancy
* Concurrent hormone replacement therapy allowed
Radiotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
* No prior radiotherapy to \> 25% of bone marrow-bearing areas
Surgery
* More than 30 days since prior major surgery and recovered
* Diagnostic biopsy not considered major surgery
Other
* At least 3 weeks since other prior therapy for the malignancy
* No prior tyrosine kinase inhibitors that target the EGFR pathway
* No prior cancer treatment that would preclude study treatment
* No other concurrent investigational agents
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Bristol-Myers Squibb
INDUSTRY
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Angeles A. Secord, MD
Role: STUDY_CHAIR
Duke Cancer Institute
Deborah K. Armstrong, MD
Role:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Nita Maihle, PhD
Role:
Yale University
Locations
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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Women's Cancer Center - Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
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
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
Hinsdale, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler Air Force Base
Keesler Air Force Base, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Camden, New Jersey, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore University Hospital
Manhasset, 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
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Gynecologic Oncology Network
Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 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
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
Burlington, Vermont, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, Australia
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
Kagoshima City Hospital
Kagoshima, , Japan
Norwegian Radium Hospital
Oslo, , Norway
Countries
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References
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Secord AA, Blessing JA, Armstrong DK, Rodgers WH, Miner Z, Barnes MN, Lewandowski G, Mannel RS; Gynecologic Oncology Group. Phase II trial of cetuximab and carboplatin in relapsed platinum-sensitive ovarian cancer and evaluation of epidermal growth factor receptor expression: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Mar;108(3):493-9. doi: 10.1016/j.ygyno.2007.11.029. Epub 2008 Jan 14.
Other Identifiers
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BMS-CA225-019
Identifier Type: -
Identifier Source: secondary_id
CDR0000371712
Identifier Type: -
Identifier Source: secondary_id
GOG-0146P
Identifier Type: -
Identifier Source: org_study_id
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