Transitional Cell Carcinoma Clinical Trial
Official title:
A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma
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 .
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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