Ovarian Cancer Clinical Trial
Official title:
A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells. It is not yet known whether
giving monoclonal antibody therapy is more effective than a placebo in treating patients
with ovarian epithelial, fallopian tube, or peritoneal cancer who have responded to surgery
and chemotherapy.
PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy
in treating patients with residual disease from stage III or stage IV ovarian epithelial,
fallopian tube, or peritoneal cancer following surgery and chemotherapy.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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