A Phase III Randomized Trial of Cisplatin (NSC #119875) With Paclitaxel (NSC #125973) Administered by Either 24 Hour Infusion or 96 Hour Infusion in Patients With Selected Stage III and Stage IV Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma
OBJECTIVES: I. Compare progression free and overall survival and frequency of response in
patients with suboptimal stage III or IV ovarian epithelial cancer or primary peritoneal
cancer treated with a 24 hour vs 96 hour infusion of paclitaxel (TAX) followed by cisplatin.
II. Determine the incidence and severity of adverse events, including catheter complications
and drug toxicity, for the 96 hour infusion of TAX. III. Compare the relationship between
plasma TAX concentrations, toxicity, and response to both infusion schedules in this patient
population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and measurable disease (yes vs no). Patients are randomized into one of
two treatment arms. Arm I: Patients receive paclitaxel IV continuously over 24 hours
followed by cisplatin IV over 2 hours. Arm II: Patients receive paclitaxel IV continuously
over 96 hours followed by cisplatin IV over 2 hours. Treatment repeats every 3 weeks for 6
courses.
PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study over 4.5 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
David R. Spriggs, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000064554
NCT00002717
March 1996
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 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington, District of Columbia 20007 |
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 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
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 |
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 |
Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
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 |
Women's Cancer Center | Palo Alto, California 94304 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
CCOP - Baptist Cancer Institute | Memphis, Tennessee 38117 |
CCOP - Central Illinois | Springfield, Illinois 62526 |