Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Maintenance Sunitinib Versus Placebo After Chemotherapy for Patients with Advanced Urothelial Carcinoma: Scientific Rationale and Study Design

Systemic chemotherapy is the primary treatment modality for patients with advanced urothelial cancer. However, despite a high Initials response rate, durable responses are rare. Angiogenesis has been shown to be important in the development and progression of urothelial cancer. Sunitinib, an oral, multi-targeted, small-molecule inhibitor of multiple tyrosine kinases, is known to inhibit angiogenesis and therefore might decrease progression of urothelial cancer. This phase II trial was designed to investigate the role of sunitinib as maintenance therapy in patients with advanced urothelial cancer. The specific hypothesis of this trial is that sunitinib will decrease progression rates in patients with advanced urothelial cancer who have obtained stable disease or better after standard chemotherapy.