Conditions: Bladder Cancer
Keywords: Advanced/Metastatic Bladder Carcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 17
Healthy volunteers: no

Brief summary:
This is a Phase II, nonrandomized multicenter study designed to evaluate time to progression and response proportion of patients with advanced or metastatic transitional cell carcinoma of bladder receiving 6 cycles of gemcitabine, carboplatin and sorafenib and then maintenance sorafenib.

Detailed description:

Arms:
arm 1: Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone

Interventions: intervention 1: Gemcitabine intervention 2: Carboplatin intervention 3: Sorafenib
Intervention descriptions: intervention 1: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8. intervention 2: Carboplatin will be given on day 1 to an AUC of 5. intervention 3: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid

Protocol document: