Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have ovarian epithelial cancer that has not responded to previous chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Glasgow
• Treatments: Bryostatin 1

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