Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer

Brief Summary

Detailed Description

OBJECTIVES: Primary * Determine the response rate and 4-year disease-free survival of patients with locally advanced carcinoma of the urothelium undergoing radical cystectomy treated with neoadjuvant chemotherapy comprising ifosfamide, doxorubicin, and gemcitabine followed by cisplatin, gemcitabine, and ifosfamide. Secondary * Compare perioperative morbidity and mortality of patients treated with this regimen vs historical standards. OUTLINE: Patients receive neoadjuvant chemotherapy comprising ifosfamide IV over 3 hours on days 1-4, doxorubicin IV on day 3, gemcitabine IV over 30 minutes on days 2 and 4, and filgrastim (G-CSF) subcutaneously on days 7-12 or until blood counts recover. Treatment repeats every 3 weeks for a total of 3 courses. Patients then receive cisplatin IV, gemcitabine IV over 90 minutes, and ifosfamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for a total of 4-6 courses. Four to six weeks after the completion of all neoadjuvant chemotherapy, patients undergo cystectomy. Patients are followed at 9, 12, 15, 18, 24, and 30 months and then annually thereafter. PROJECTED ACCRUAL: A total of 31-49 patients will be accrued for this study within 16-25 months.

Primary Outcomes

Secondary Outcomes

• Comparison of perioperative treatment morbidity and mortality with historical standards(Minimally reviewed following 6 weeks post treatment)