FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial Cancer
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|ClinicalTrials.gov Identifier: NCT00085527|
Recruitment Status : Withdrawn
First Posted : June 11, 2004
Last Update Posted : September 5, 2013
RATIONALE: FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory advanced ovarian epithelial cancer.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: depsipeptide||Phase 2|
- Determine the response rate (complete and partial) in patients with relapsed or refractory advanced ovarian epithelial carcinoma treated with FR901228 (depsipeptide).
- Determine the toxicity of this drug in these patients.
- Correlate clinical response with platinum sensitivity in patients treated with this drug.
- Correlate clinical response with P-glycoprotein expression or p53 status in patients treated with this drug.
OUTLINE: This is multicenter study. Patients are stratified according to response to prior platinum administration (platinum resistant vs platinum sensitive).
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20-37 patients will be accrued for this study within 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma|
|Study Start Date :||May 2005|
|Primary Completion Date :||September 2005|
|Study Completion Date :||September 2005|
U.S. FDA Resources
Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.
Other Name: Romidepsin, Istodax®
- Response rate of depsipeptide in ovarian cancer [ Time Frame: 8 weeks ]
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): NCT00085527
|United States, Illinois|
|Cardinal Bernardin Cancer Center at Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Study Chair:||Gini Fleming, MD||University of Chicago|