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

Inclusion Criteria

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