Phase II Trial of Paclitaxel, Carboplatin and Gemcitabine in Patients With Locally Advanced Transitional Cell Carcinoma of the Bladder
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel
- Conditions
- Bladder Cancer
- Sponsor
- University of Michigan Rogel Cancer Center
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Percentage of Patients in Arm I with Complete Pathologic Response
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm I
Patients with clinical stage T2 with hydronephrosis or T3 bladder cancer will receive 3 cycles of chemotherapy (200mg/m\^2 paclitaxel on day 1, carboplatin on day 1, and 800 mg/m\^2 gemcitabine on days 1 and 8 of each 21 day cycle).
Intervention: Paclitaxel
Arm I
Patients with clinical stage T2 with hydronephrosis or T3 bladder cancer will receive 3 cycles of chemotherapy (200mg/m\^2 paclitaxel on day 1, carboplatin on day 1, and 800 mg/m\^2 gemcitabine on days 1 and 8 of each 21 day cycle).
Intervention: Carboplatin
Arm I
Patients with clinical stage T2 with hydronephrosis or T3 bladder cancer will receive 3 cycles of chemotherapy (200mg/m\^2 paclitaxel on day 1, carboplatin on day 1, and 800 mg/m\^2 gemcitabine on days 1 and 8 of each 21 day cycle).
Intervention: Gemcitabine
Arm II
Patients with T4 or lymph node positive disease will receive up to 6 cycles of paclitaxel, carboplatin, and gemcitabine.
Intervention: Paclitaxel
Arm II
Patients with T4 or lymph node positive disease will receive up to 6 cycles of paclitaxel, carboplatin, and gemcitabine.
Intervention: Carboplatin
Arm II
Patients with T4 or lymph node positive disease will receive up to 6 cycles of paclitaxel, carboplatin, and gemcitabine.
Intervention: Gemcitabine
Outcomes
Primary Outcomes
Percentage of Patients in Arm I with Complete Pathologic Response
Time Frame: 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
Time Frame: 6 Cycles (126 days) of Treatment