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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Peter G. Rose, MD
Study Chair
The Cleveland Clinic
United States: Federal Government
CDR0000063600
NCT00002568
June 1994
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
Stanford University Medical Center | Stanford, California 94305-5408 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Cooper Hospital/University Medical Center | Camden, New Jersey 08103 |
Cancer Center of Albany Medical Center | Albany, New York 12208 |
State University of New York Health Science Center at Brooklyn | Brooklyn, New York 11203 |
University of Rochester Cancer Center | Rochester, New York 14642 |
State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
Cancer Center, University of Virginia HSC | Charlottesville, Virginia 22908 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Tacoma General Hospital | Tacoma, Washington 98405 |
CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
Women's Cancer Center | Palo Alto, California 94304 |
CCOP - Baptist Cancer Institute | Memphis, Tennessee 38117 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Brookview Research, Inc. | Nashville, Tennessee 37203 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
Lombardi Cancer Center, Georgetown University | Washington, District of Columbia 20007 |
North Shore University Hospital | Manhasset, New York 11030 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |