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Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer

This study has been completed.

Sponsored by: University of Glasgow
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004008
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: bryostatin 1
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

Drug Information available for:   Bryostatin 1   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Trial of Bryostatin 1 in Ovarian Cancer Administered by Weekly 24 Hour Intravenous Infusion

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 1999

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004008

Locations
United Kingdom, England
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
United Kingdom, Scotland
Royal Infirmary    
      Glasgow, Scotland, United Kingdom, G4 0SF

Sponsors and Collaborators
University of Glasgow

Investigators
Study Chair:     Gordon Jayson, MD     Christie Hospital    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067219, CRC-PHASE-II-PH2/039, NCI-T99-0027
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004008
Health Authority:   United States: Federal Government

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  

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Bryostatin 1
Ovarian epithelial cancer
Recurrence
Genital Diseases, Female
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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