Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896)

BACKGROUND Chemotherapy options for the patients with advanced urothelial carcinoma and renal dysfunction are limited. The authors performed a Phase II trial of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction. METHODS Forty-two patients were accrued; 37 eligible patients were treated. Patients received paclitaxel 225 mg/m2 over three hours followed by carboplatin targeted area under the concentration-time curve = 6 mg/mL · minute every three weeks for up to six cycles. RESULTS The median number of cycles received was four (range, one to six). The objective response rate was 24.3% (95% confidence interval, 11.9–41.7%). The median progression free survival was 3 months and the median overall survival was 7.1 months. The number of poor prognostic risk factors (Eastern Cooperative Oncology Group performance status > 1 or lung, liver, or bone metastases) significantly predicted for survival. The most common ≥ 1 Grade 3 toxicities included granulocytopenia (60%) and neurotoxicity (35%). CONCLUSIONS Paclitaxel/carboplatin is a chemotherapy option for patients with advanced urothelial carcinoma and renal dysfunction. Future trials in chemotherapy development for this patient population are warranted. Cancer 2002;95:1022–7. © 2002 American Cancer Society. DOI 10.1002/cncr.10782