bryostatin 1 in treating patients with ovarian epithelial cancer

Conditions: Ovarian Cancer

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.

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.

Eligibility 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

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