A Phase II/III Trial of Chemotherapy Alone Versus Chemotherapy Plus SCH 58500 in Newly Diagnosed Stage III Ovarian and Primary Peritoneal Cancer Patients With Greater Than or Equal to 0.5 cm and Less Than or Equal to 2 cm Residual Disease Following Surgery
OBJECTIVES: I. Assess the effect of paclitaxel and carboplatin with or without SCH 58500 on
progression free survival, overall survival, safety, response, and CA-125 levels in patients
with newly diagnosed stage III ovarian epithelial or primary peritoneal cancer.
OUTLINE: This is a randomized, open label, multicenter study. Patients receive treatment of
IV paclitaxel and IV carboplatin. Patients are randomized to one of two treatment groups:
Arm I: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin,
on day 1. Courses are repeated every 21 days. Arm II: Patients receive IV paclitaxel over 3
hours, immediately followed by IV carboplatin, on day 1. Patients receive intraperitoneal
SCH 58500 on days 1-5. Courses are repeated every 21 days. Patients are followed every 6
weeks for 36 months, then every 3 months for 2 years, and then every 6 months until disease
progression.
PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Jo Ann Horowitz, MD
Study Chair
Schering-Plough
United States: Federal Government
CDR0000067047
NCT00003880
February 1999
Name | Location |
---|---|
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 |
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 Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
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 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
New York Medical College | Valhalla, New York 10595 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Lombardi Cancer Center, Georgetown University | Washington, District of Columbia 20007 |
St. Barnabas Medical Center | Livingston, New Jersey 07039 |
Texas Oncology, P.A. | Dallas, Texas 75246 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Wesley Medical Center | Wichita, Kansas 67214 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Greenville Hospital System | Greenville, South Carolina 29605 |
Providence Hospital Cancer Center | Southfield, Michigan 48075 |
Walt Disney Memorial Cancer Institute | Orlando, Florida 32803 |
University of New Mexico School of Medicine | Albuquerque, New Mexico 87131 |
University of Florida Health Science Center - Jacksonville | Jacksonville, Florida 32209 |
Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
Woman's Hospital | Baton Rouge, Louisiana 70815 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Loma Linda University Cancer Institute | Loma Linda, California 92354 |
Rocky Mountain Gynecologic Oncology | Englewood, Colorado 80110 |
Southeastern Gynecologic Oncology | Decatur, Georgia 30033 |
Ochsner Cancer Institute | New Orleans, Louisiana 70121 |
Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
G. Rainey Williams Pavilion | Oklahoma City, Oklahoma 73190 |
Mercy Cancer Institute | Pittsburgh, Pennsylvania 15219 |
Pacific Gynecology Specialists | Seattle, Washington 98104 |