Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC
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 .
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma|
- Response rate [ Time Frame: 2000~2006 ]
- Overall Survival, Safety [ Time Frame: 2000~2006 ]
|Study Start Date:||May 2000|
|Study Completion Date:||June 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00173862
|Department of Oncology , National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Chih-Hung Hsu, M.D., Ph.D.||Department of Oncology , National Taiwan University Hospital|
|Study Chair:||Ann-Lii Cheng, M.D., Ph.D.||Department of Oncology, National Taiwan University Hospital|