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

Date de début de l'étude : 1 novembre 1998

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