FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial Cancer
- Conditions
- Ovarian Cancer
- Interventions
- Drug: depsipeptide
- Registration Number
- NCT00085527
- Lead Sponsor
- University of Chicago
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description depsipeptide depsipeptide Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.
- Primary Outcome Measures
Name Time Method Response rate of depsipeptide in ovarian cancer 8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States