Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: bryostatin 1


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bryostatin 1|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer