Spots Global Cancer Trial Database for Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
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Trial Identification
Brief Title: Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
Official Title: A PHASE III RANDOMIZED STUDY OF CISPLATIN (NSC #119875) AND TAXOL (PACLITAXEL) (NSC #125973) WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III & IV EPITHELIAL OVARIAN CARCINOMA
Study ID: NCT00002568
Conditions
Study Description
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 or combining chemotherapy with surgery may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin with or without surgery in treating patients with stage III ovarian epithelial cancer.
Detailed Description: OBJECTIVES: I. Determine whether secondary cytoreductive surgery improves the progression-free interval and survival in patients with suboptimally resected stage III ovarian epithelial carcinoma treated with paclitaxel/cisplatin. II. Determine the morbidity of secondary cytoreductive surgery in these patients. III. Assess prospectively the quality of life (QOL) of these patients and determine whether secondary cytoreductive surgery affects QOL. OUTLINE: Randomized study. Following treatment on Regimen A, patients with stable or objective response are randomized to Arms I and II. Regimen A: 2-Drug Combination Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, NSC-125973; Cisplatin, CDDP, NSC-119875. Arm I: Surgery followed by 2-Drug Combination Chemotherapy. Laparotomy with resection of residual disease; followed by Taxol/CDDP. Arm II: 2-Drug Combination Chemotherapy. Taxol; CDDP. PROJECTED ACCRUAL: Approximately 470 patients will be entered over 20 months to provide 400 evaluable patients.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States
CCOP - Greater Phoenix, Phoenix, Arizona, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
Women's Cancer Center, Palo Alto, California, United States
Stanford University Medical Center, Stanford, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Lombardi Cancer Center, Georgetown University, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Cooper Hospital/University Medical Center, Camden, New Jersey, United States
Morristown Memorial Hospital, Morristown, 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
North Shore University Hospital, Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, 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
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States
CCOP - Columbia River Program, Portland, Oregon, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
CCOP - Baptist Cancer Institute, Memphis, Tennessee, United States
Brookview Research, Inc., Nashville, Tennessee, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Cancer Center, University of Virginia HSC, Charlottesville, Virginia, United States
University of Washington Medical Center, Seattle, Washington, United States
Tacoma General Hospital, Tacoma, Washington, United States
Contact Details
Name: Peter G. Rose, MD
Affiliation: The Cleveland Clinic
Role: STUDY_CHAIR
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