A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate of depsipeptide in ovarian cancer
8 weeks
No
Gini Fleming, MD
Study Chair
University of Chicago
United States: Federal Government
12965A
NCT00085527
May 2005
September 2005
Name | Location |
---|---|
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |