A Randomized, Double-Blind, Placebo-Controlled, Phase IIB Study of the Safety and Efficacy of OVAREX MabB43.13 in Ovarian Cancer Patients With an Elevated Serum CA 125 But Without Other Evidence of Disease
OBJECTIVES: I. Determine the safety of OvaRex monoclonal antibody B43.13 in patients with
elevated CA 125 and histologically proven epithelial adenocarcinoma of the ovary, fallopian
tube, or peritoneum, but without other evidence of disease. II. Determine the time to
disease progression, overall survival, CA 125 levels, immune responses, and quality of life
of these patients treated with this regimen.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms: Arm I: Patients receive placebo IV during weeks 1, 3, 5, 9, 13, 25, 37, and
49. Arm II: Patients receive OvaRex monoclonal antibody B43.13 (MOAB B43.13) IV during weeks
1, 3, 5, 9, 13, 25, 37, and 49. Patients in either treatment arm who have no disease
progression after week 49 receive MOAB B43.13 once every 12 weeks until week 121. Patients
with disease progression after week 49 may receive MOAB B43.13 alone, in combination with,
or following chemotherapy. Quality of life is assessed during the study.
PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Michael A. Bookman, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000067265
NCT00004064
November 1998
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Cancer Center, University of Virginia HSC | Charlottesville, Virginia 22908 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Texas Oncology, P.A. | Dallas, Texas 75246 |
Palmetto Richland Memorial Hospital | Columbia, South Carolina 29203 |
Walt Disney Memorial Cancer Institute | Orlando, Florida 32803 |
St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Mercy Medical Center, Inc. | Baltimore, Maryland 21202 |
Gynecologic Oncology Associates | Newport Beach, California 92663 |
Lee Memorial Health System | Fort Myers, Florida 33902 |
Riverside Regional Medical Center | Newport News, Virginia 23601 |