Monoclonal Antibody Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
- Conditions
- Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00004064
- Lead Sponsor
- AltaRex
- Brief Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian, fallopian tube, or peritoneal cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 102
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Gynecologic Oncology Associates
🇺🇸Newport Beach, California, United States
Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Palmetto Richland Memorial Hospital
🇺🇸Columbia, South Carolina, United States
Texas Oncology, P.A.
🇺🇸Dallas, Texas, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
Walt Disney Memorial Cancer Institute
🇺🇸Orlando, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Mercy Medical Center, Inc.
🇺🇸Baltimore, Maryland, United States
St. John's Mercy Medical Center
🇺🇸Saint Louis, Missouri, United States
Cancer Center, University of Virginia HSC
🇺🇸Charlottesville, Virginia, United States
Riverside Regional Medical Center
🇺🇸Newport News, Virginia, United States
Ottawa Regional Cancer Center - General Division
🇨🇦Ottawa, Ontario, Canada
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States