FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial Cancer
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma|
- Response rate of depsipeptide in ovarian cancer [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.
Other Name: Romidepsin, Istodax®
- 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.
|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|