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Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004008
Recruitment Status : Completed
First Posted : May 8, 2003
Last Update Posted : June 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: bryostatin 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Bryostatin 1 in Ovarian Cancer Administered by Weekly 24 Hour Intravenous Infusion
Study Start Date : July 1999
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004008


Locations
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United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Royal Infirmary
Glasgow, Scotland, United Kingdom, G4 0SF
Sponsors and Collaborators
University of Glasgow
Investigators
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Study Chair: Gordon Jayson, MD The Christie NHS Foundation Trust
More Information
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ClinicalTrials.gov Identifier: NCT00004008    
Other Study ID Numbers: CRC-PHASE-II-PH2/039
CDR0000067219 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-T99-0027
First Posted: May 8, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: November 1999
Keywords provided by National Cancer Institute (NCI):
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
 Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bryostatin 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents