title: 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.
abstract: Systemic chemotherapy is the primary treatment modality for patients with advanced urothelial cancer. However, despite a high initial 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.
authors.affiliation: University of Michigan, Ann Arbor, MI 48109-0946, USA.
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Bradley
authors.forename: Rodney
authors.initials: R
authors.lastname: Dunn
authors.forename: David
authors.initials: D
authors.lastname: Nanus
authors.forename: Walter
authors.initials: W
authors.lastname: Stadler
authors.forename: Robert
authors.initials: R
authors.lastname: Dreicer
authors.forename: Jonathan
authors.initials: J
authors.lastname: Rosenberg
authors.forename: David C
authors.initials: DC
authors.lastname: Smith
authors.forename: Maha
authors.initials: M
authors.lastname: Hussain
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D023381:Endpoint Determination; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D040262:Receptors, Vascular Endothelial Growth Factor / Q000097:blood; D012107:Research Design; D000077210:Sunitinib; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*; D042461:Vascular Endothelial Growth Factor A / Q000097:blood
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D042461:Vascular Endothelial Growth Factor A; D040262:Receptors, Vascular Endothelial Growth Factor; D000077210:Sunitinib