Ovarian Cancer Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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