Bladder Cancer
Conditions
Keywords
Neoadjuvant chemotherapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGPaclitaxel
DRUGCarboplatin
DRUGGemcitabine
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients in Arm I with Complete Pathologic Response | 3 Cycles (63 days) of 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. |
| Percentage of Patients in Arm II that Obtain to Resectable Disease | 6 Cycles (126 days) of Treatment | — |
Countries
United States
Outcome results
None listed