A Phase II Trial of Bryostatin 1 in Ovarian Cancer Administered by Weekly 24 Hour Intravenous Infusion

Date de début de l'étude : 1 juillet 1999

DISEASE CHARACTERISTICS: Histologically proven ovarian epithelial cancer Progressive disease during or after completion of at least one platinum based chemotherapy regimen Bidimensionally measurable disease At least 2 cm by x-ray, CT scan, or ultrasound No active, symptomatic brain metastases (e.g., cerebral edema and/or progressive tumor growth) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.7 mg/dL AST/ALT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.4 mg/dL Other: No active, uncontrolled infection No nonmalignant systemic disease which would increase risk to patient No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No more than 2 prior multidrug chemotherapy regimens No more than 1 prior single agent chemotherapy regimen Endocrine therapy: At least 4 weeks since prior endocrine therapy and recovered No concurrent steroids Concurrent hormone replacement therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy (excluding palliative therapy) and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major thoracic or abdominal surgery Other: No other concurrent anticancer therapy or investigational drugs