Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer

University of Glasgow

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: bryostatin 1

Study type: Interventional

Funder types: Other

Identifiers

NCT00004008

NCI-T99-0027

CRC-PHASE-II-PH2/039

CDR0000067219 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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