Phase II trial of weekly paclitaxel in patients with previously treated advanced urothelial cancer.

PURPOSE

We evaluated the efficacy and toxicity of weekly paclitaxel in patients with previously treated advanced urothelial cancer.

PATIENTS AND METHODS

Patients with urothelial cancer who had received one prior systemic chemotherapy regimen for advanced disease and had evidence of disease progression were eligible for enrollment. Patients received paclitaxel 80 mg/m(2) by 1-hour intravenous infusion weekly. A cycle of therapy consisted of four weekly treatments.

RESULTS

The study enrolled 31 patients. Mean age was 66 years, and 45% of patients had three or more involved metastatic sites. Only 26% of patients had responded to prior chemotherapy. The median number of cycles delivered was three (range, one to eight) at a mean weekly paclitaxel dose of 79 mg/m(2). Three patients achieved a partial response (10%; 95% confidence interval, 0% to 20%). Median time to progression was 2.2 months, and median overall survival time was 7.2 months. Therapy was well tolerated with minimal hematologic toxicity. Grade 3 nonhematologic toxicities were also uncommon.

CONCLUSION

Although the overall response rate to weekly paclitaxel in patients with previously treated advanced urothelial cancer was modest, the chemotherapy-refractory nature of the study population should be considered.