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Sponsored by: |
University of Glasgow |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004008 |
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 |
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Ovarian Cancer |
Drug: bryostatin 1 |
Phase II |
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 |
Study Start Date: | July 1999 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven ovarian epithelial cancer
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
Study Chair: | Gordon Jayson, MD | Christie Hospital NHS Foundation Trust |
Study ID Numbers: | CDR0000067219, CRC-PHASE-II-PH2/039, NCI-T99-0027 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004008 History of Changes |
Health Authority: | United States: Federal Government |
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer |
Ovarian Neoplasms Immunologic Factors Gonadal Disorders Adjuvants, Immunologic Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Bryostatin 1 Ovarian Epithelial Cancer Recurrence Genital Diseases, Female Ovarian Cancer Endocrinopathy Endocrine Gland Neoplasms |
Ovarian Neoplasms Immunologic Factors Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms |
Ovarian Diseases Bryostatin 1 Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Therapeutic Uses Endocrine Gland Neoplasms |