A comparison of cisplatin and the combination of cisplatin and cyclophosphamide in advanced urothelial cancer. A National Bladder Cancer Collaborative Group A Study.

A prospective multi-institutional randomized trial compared the use of cisplatin (DDP) alone to the combination of DDP and cyclophosphamide in patients with advanced urothelial cancer. Patients were stratified according to measurable or evaluable tumor and performance status. The dose of DDP was 70 mg/m2 and the initial dose of cyclophosphamide was 750 mg/m2. There were ten objective responders (20%), including five complete responders, among the 50 evaluable patients who received DDP alone, and seven responders (11.9%), three complete, among the 59 receiving the combination therapy. Approximately one third of the patients in each treatment arm were stable at the nine-week evaluation. There was no statistical significance between the response rates in the two treatment arms.