Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer
|ClinicalTrials.gov Identifier: NCT00004008|
Recruitment Status : Completed
First Posted : May 8, 2003
Last Update Posted : June 26, 2013
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|
- 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 Type :||Interventional (Clinical Trial)|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004008
|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|
|Glasgow, Scotland, United Kingdom, G4 0SF|
|Study Chair:||Gordon Jayson, MD||The Christie NHS Foundation Trust|