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Clinical Trials/NCT00004008
NCT00004008CompletedPhase 2

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

University of Glasgow8 sites in 1 countryStarted: July 1, 1999Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Locations
8
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

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.

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts 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:
  • •18 and over
  • •Performance status:
  • •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
  • •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)
  • •Creatinine no greater than 1.4 mg/dL
  • •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
  • •At least 4 weeks since prior major thoracic or abdominal surgery
  • •No other concurrent anticancer therapy or investigational drugs

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Other

Study Sites (8)

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