Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00173862
Status:
COMPLETED
Last Update Posted:
2007-07-25
First Post:
2005-06-30
Brief Title:
Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2005-06
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:
The purpose of this study is to evaluate the efficacy of Gemcitabine plus Ifosfamind as second line chemotherapy in advanced transitional cell carcinoma in terms of response rate and overall survival
Detailed Description:
Cisplatin-based combination chemotherapy produces a response rate of 40-70 in TCC patients However only less than 10 of the patients can achieve long-term remission Until now there is no standard chemotherapy for cisplatin-failed TCC patients Both gemcitabine and ifosfamide have been identified to have response rates of 20 or more in pretreated TCC patients It is thus reasonable to combine these two active drugs as a second-line treatment for TCC
Patients enrolled must have a pathologically proven urothelial transitional cell carcinoma TCC and must have exposed to one cisplatin-based combination chemotherapy for the advanced disease GI regimen will be continued until maximal response
Patients enrolled must have a pathologically proven urothelial transitional cell carcinoma TCC and must have exposed to one cisplatin-based combination chemotherapy for the advanced disease GI regimen will be continued until maximal response
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