Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087295
Status:
TERMINATED
Last Update Posted:
2012-11-02
First Post:
2004-07-08
Brief Title:
S0400 FR901228 in Treating Patients With Advanced Cancer of the Urothelium
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Permanently Closed Due to Poor Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S0400 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |