Clinical Trials Search
Clinical Trial 17924
Cancer Type: Genitourinary
Interventions:Enzalutamide; Gemzar (gemcitabine); cisplatin; gemcitabine
Study Type: Treatment
Phase of Study: Phase I
- Jingsong Zhang
A Phase I/1b Study of Enzalutamide in Combination with Gemcitabine and Cisplatin in Bladder Cancer
The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and cisplatin in patients with advanced bladder cancer. Researchers also want to find out the side effects of these drugs when given together. This study will also help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine and cisplatin.
To determine the safety and tolerability of enzalutamide at doses of 80 mg and 160 mg each in combination with gemcitabine and cisplatin in advanced bladder cancer. Once the safety of the combination is established, the phase 1 cohort will be expanded to an additional cohort of 12 patients with stage IV bladder cancer (phase 1b), who express androgen receptor (AR) by immunohistochemistry (IHC), to determine the safety and tolerability of enzalutamide and gemcitabine and cisplatin in this expanded cohort of patients with AR+ bladder cancer.