S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium
- Conditions
- Bladder CancerTransitional Cell Cancer of the Renal Pelvis and UreterUrethral Cancer
- Interventions
- Drug: Depsipeptide
- Registration Number
- NCT00087295
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as FR901228 (depsipeptide), work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with advanced cancer of the urothelium that has progressed or recurred after receiving one chemotherapy regimen.
- Detailed Description
OBJECTIVES:
* Determine the response (confirmed complete and partial) in patients with advanced transitional cell carcinoma of the urothelium that has progressed after prior chemotherapy when treated with FR901228 (depsipeptide) .
* Determine progression-free and overall survival of patients treated with this drug.
* Determine the qualitative and quantitative toxic effects of this drug in these patients.
* Determine, preliminarily, the effects of this drug on reversing tumor promoter gene methylation in these patients.
* Correlate, preliminarily, tumor DNA in plasma with response or outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
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. Patients achieving a complete response receive 2 additional courses of treatment.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Depsipeptide Depsipeptide
- Primary Outcome Measures
Name Time Method Probability of response (confirmed complete and partial) From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
- Secondary Outcome Measures
Name Time Method Progression-free survival From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years Overall survival From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years Number and grade of adverse events From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years