Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer
Status:
Unknown status
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
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.