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

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven epithelial adenocarcinoma of the ovary,
fallopian tube, or peritoneum CA 125 greater than 35 U/mL No conclusive radiological or
clinical evidence of disease No disease recurrence Must have received only 1 prior
platinum based chemotherapy regimen No tumors of low malignant potential or noninvasive
disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 6 months Hematopoietic: Hemoglobin at least 8.0 g/dL Lymphocyte count at least
1,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 2 mg/dL
Cardiovascular: No uncontrolled hypertension No congestive heart failure No arrhythmias
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No active autoimmune disease requiring chronic treatment No allergy to
murine proteins No documented anaphylactic reaction to any drug No active infection
causing fever No immunodeficiency disease No uncontrolled nonmalignant diseases No other
malignancy (except nonmelanomatous skin cancer or carcinoma in situ of the cervix) unless
curatively treated and free of disease for at least 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibodies
Chemotherapy: See Disease Characteristics At least 4 weeks since prior platinum based
chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At
least 6 months since prior limited field (i.e., abdominal or pelvic) radiotherapy No prior
whole abdominal radiotherapy Surgery: At least 4 weeks since prior surgery No prior
splenectomy Other: At least 4 weeks since prior immunosuppressive drugs No concurrent
immunosuppressive drugs At least 30 days since other prior investigational drugs