A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma
OBJECTIVES: I. Compare the time to disease relapse, survival, and quality of life of
patients with stage III or IV ovarian epithelial, tubal, or peritoneal adenocarcinoma
treated with OvaRex monoclonal antibody B43.13 OR placebo following complete clinical
response to primary therapy. II. Determine the safety of this regimen in these patients.
III. Assess the immune response of patients treated with this regimen.
OUTLINE: This is a randomized study. Patients undergo a laparotomy and platinum based
chemotherapy prior to randomization. Patients are randomized to 1 of 2 treatment arms: Arm
I: Patients receive OvaRex monoclonal antibody B43.13 IV on day 0. Treatment continues at 4,
8, 20, 32, 44, and 56 weeks, and then every 3 months in the absence of disease progression
or unacceptable toxicity. Arm II: Patients receive placebo IV on day 0. Placebo
administration continues on the same schedule as in arm I. Patients presenting with relapse
are provided with second line chemotherapy. Quality of life is assessed at the beginning of
the study, after 2 months, and then every 3 months thereafter. Patients are followed every 3
months.
PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Jonathan S. Berek, MD
Study Chair
Jonsson Comprehensive Cancer Center
United States: Federal Government
CDR0000066718
NCT00003634
April 1998
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 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Cancer Center, University of Virginia HSC | Charlottesville, Virginia 22908 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
Baptist Regional Cancer Center - Knoxville | Knoxville, Tennessee 37901 |
Henry Ford Hospital | Detroit, Michigan 48202 |
University of Minnesota Medical School | Minneapolis, Minnesota 55455 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
North Shore University Hospital | Manhasset, New York 11030 |
Swedish Hospital Tumor Institute | Seattle, Washington 98104 |
University of Texas Southwestern Medical School | Dallas, Texas 75235-9032 |
Walt Disney Memorial Cancer Institute | Orlando, Florida 32803 |
Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
University of Florida Health Science Center - Jacksonville | Jacksonville, Florida 32209 |
Wilshire Oncology Medical Center | Pomona, California 91767 |
Stanford University School of Medicine | Stanford, California 94305-5317 |
Patty Berg Cancer Center | Fort Myers, Florida 33901 |
Saint Mary's Hospital | East Saint Louis, Illinois 62201 |
Alton Ochsner Medical Foundation Hospital | New Orleans, Louisiana 70121 |
Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
University of Oklahoma | Oklahoma City, Oklahoma 73190 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
U.S. Oncology | Houston, Texas 77060 |