Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066612
Status:
COMPLETED
Last Update Posted:
2012-11-02
First Post:
2003-08-06
Brief Title:
S0306 Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 irinotecan use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent or refractory advanced transitional cell cancer of the urothelium
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent or refractory advanced transitional cell cancer of the urothelium
Detailed Description:
OBJECTIVES
Determine the probability of response confirmed complete and partial response to treatment with irinotecan in patients with recurrent or refractory advanced transitional cell carcinoma of the urothelium previously treated with platinum-based chemotherapy
Determine the qualitative and quantitative toxic effects of this drug in these patients
Determine the overall and progression-free survival of patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to prior pelvic radiotherapy yes vs no
Patients receive irinotecan IV over 90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
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 within 5-10 months
Determine the probability of response confirmed complete and partial response to treatment with irinotecan in patients with recurrent or refractory advanced transitional cell carcinoma of the urothelium previously treated with platinum-based chemotherapy
Determine the qualitative and quantitative toxic effects of this drug in these patients
Determine the overall and progression-free survival of patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to prior pelvic radiotherapy yes vs no
Patients receive irinotecan IV over 90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
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 within 5-10 months
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 |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0306 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |