Phase II Trial of Paclitaxel, Carboplatin and Gemcitabine in Patients With Locally Advanced Transitional Cell Carcinoma of the Bladder
This is a Phase II trial of neoadjuvant chemotherapy with paclitaxel, carboplatin and
gemcitabine in the treatment of locally advanced transitional cell carcinoma of the bladder.
Patients will be stratified based on extent of disease. Patients with T3, N0 disease will
receive 3 cycles of chemotherapy and then proceed to cystectomy. Patients with T4 disease or
any patient with N1-3 disease will receive 3 cycles of therapy followed by assessment of
response. Patients with evidence of response will then receive an additional three cycles of
therapy with reassessment of resectability after cycles #6. Correlative Studies: Tumor
specimens obtained at initial biopsy will be assayed for expression of p53, Rb and p21.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the overall response measured as complete pathologic response and conversion to resectability of the combination of paclitaxel, carboplatin and gemcitabine in patients with locally advanced transitional cell carcinoma of the bladder
David C. Smith, MD
The University of Michigan Comprehensive Cancer Center
United States: Institutional Review Board
|The University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109|