NCT00173862

Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC

A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transitional Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine, Ifosfamide

Timeline

• Start date: 2000-05-01
• Completion: 2006-06-01
• First posted: 2005-09-15
• Last updated: 2007-07-25

Locations

1 site across 1 country: Taiwan