Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2003-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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bryostatin 1

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No