S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium
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.
Transitional Cell Cancer of the Renal Pelvis and Ureter
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Depsipeptide (NSC-630176) In Patients With Advanced Transitional Cell Carcinoma Of The Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen For Advanced Disease|
- Probability of response (confirmed complete and partial) [ Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years ]
- Progression-free survival [ Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years ]
- Overall survival [ Time Frame: 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 [ Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years ]
|Study Start Date:||June 2004|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Depsipeptide wil be given 13 mg/m^2 through an intravenous (IV) over 4 hours on day 1, 8, and 15 for every 28 days (1 cycle = 28 days) until progression. Patients achieving a complete response (CR) will receive two additional cycles of treatment, and then be removed from protocol treatment.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087295
|Study Chair:||Daniel P. Petrylak, MD||Herbert Irving Comprehensive Cancer Center|