Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer

Summary

Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a similar efficacy but less toxicity. Almost all responding patients relapse within the first year, with a median survival of 12 months. Prognosis is very poor in patients who display progressive disease after receiving combination cisplatin-based chemotherapy. No standard has yet been established for second-line treatment and well designed trials of second-line chemotherapy for metastatic transitional carcinoma of the urothelium should be given high priority. Several drugs have been used in second line for metastatic disease with poor results. The investigators have planned a Phase II study, open-label, single arm design to evaluate the activity and safety of sunitinib in metastatic urothelial carcinoma, pretreated with standard regimen (cisplatin-gemcitabine). No previous studies have been published with sunitinib in metastatic bladder cancer.

Timeline

Start

2009-01

Primary completion

2009-08

Completion

2011-01

Drugs

Indications