This trial will evaluate the efficacy and safety of combination chemotherapy (paclitaxel,
carboplatin, and gemcitabine) prior to surgery in the treatment of patients with locally
advanced transitional cell cancer 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.
- Patients must have histologically proven locally advanced (T3-4, N0 or Tany, N1-3)
urothelial carcinoma of the bladder. Patients with local disease and unilateral or
bilateral hydronephrosis will be eligible and included in the T3 arm of the study.
- Tumor specimens must be available for assay of molecular markers.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 2 (a measure of
general well being where 0 is asymptomatic and 5 is death)
- Life expectancy of 12 weeks or more
- Adequate bone marrow, renal and hepatic function
- Patients may not have had prior systemic or intra-arterial chemotherapy and no prior
radiotherapy (Patients may have received intravesicular chemotherapy).
- Evidence of distant metastasis
- Unresolved bacterial infection