A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma
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
Chih-Hung Hsu, M.D., Ph.D.
Department of Oncology , National Taiwan University Hospital
Taiwan: Department of Health