Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer
- 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.
- Compare perioperative morbidity and mortality of patients treated with this regimen vs
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
6 weeks following treatment
Randall E. Millikan, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|