Phase II study of paclitaxel and cisplatin for advanced urothelial cancer

Purpose: We examined the role of paclitaxel and cisplatin as first line therapy for metastatic urothelial cancer. Materials and Methods: A total of 34 patients were enrolled in this study, and all were eligible for treatment and assessable for response. Patients received 135 mg./m.² paclitaxel intravenously for 3 hours followed by 70 mg./m.² cisplatin for 2 hours every 3 weeks to a maximum of 6 cycles. Results: Of the patients 70% experienced a major response to treatment, which was partial/regression in 38% and complete in 32%. Toxicity was manageable with no episodes of grade 4 leukopenia or thrombocytopenia. Nonhematological toxicities included primarily nausea, anorexia and neuropathy, which rarely were severe. Conclusions: This regimen of paclitaxel and cisplatin is effective, safe and convenient to administer in an outpatient setting for advanced urothelial cancer.