Phase II study of a polyethoxylated castor oil–free, polymeric micelle formulation of paclitaxel for patients with advanced urothelial cancer previously treated with gemcitabine and platinum.

272 Background: Paclitaxel-loaded polymeric micelle (Genexol-PM; G-PM) is a novel polyethoxylated castor oil (Cremophor EL [CrEL])-free formulation of paclitaxel. This multicenter phase II study was designed to evaluate the efficacy and safety of the G-PM monotherapy for the treatment of gemcitabine- and cisplatin-refractory advanced urothelial cancer. Methods: Patients with advanced urothelial cancer received G-PM 240 mg/m2 intravenously over 3 hours every 3 weeks without premedication as salvage chemotherapy after failure to gemcitabine and cisplatin combination chemotherapy. Intrapatient dose escalation of G-PM to 300 mg/m2 was carried out from the second cycle if the prespecified toxicities were not observed after the first cycle. Results: Thirty-seven patients were enrolled in this study. Platinum-free interval was less than 6 months in 72% of patients and 64% of patients were categorized into intermediate or poor prognostic group. Overall response rate was 19% including one complete response. When r...