Ovarian Cancer
Conditions
Keywords
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer
Brief 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.
Detailed description
OBJECTIVES: * Evaluate the antitumor activity and toxicity of bryostatin 1 in patients with platinum resistant ovarian epithelial cancer. * Determine the response rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive bryostatin 1 IV over 24 hours. Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or regressive disease may receive additional treatment. Patients are followed for at least 4 weeks after treatment, then every 3 months. PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Interventions
DRUGbryostatin 1
Sponsors
University of Glasgow
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United Kingdom
Outcome results
None listed