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.

Condition	Intervention	Phase
Bladder Cancer	Drug: Paclitaxel, Carboplatin, Gemcitabine	Phase II

Further Study Details: 

Primary Outcomes: 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 o
Secondary Outcomes: To explore the relationship between response and tumor expression of molecular markers including p53, retinoblastoma protein (Rb) and p21, and the relationship between overall survival and expression of p53, Rb, and p21.
Expected Total Enrollment:  87

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.
• Patients may not have had prior systemic or intra-arterial chemotherapy and no prior radiotherapy. (Patients may have received intravesicular chemotherapy.)
• Tumor specimens must be available for assay of molecular markers.

Please refer to this study by ClinicalTrials.gov identifier  NCT00136175

David C. Smith, MD      734-936-8906 
Cancer AnswerLine      1-800-865-1125 

Michigan
      The University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109,  United States; Recruiting

Study chairs or principal investigators

David C. Smith, MD,  Principal Investigator,  The University of Michigan Comprehensive Cancer Center   

Study ID Numbers:  UMCC 9910
Last Updated:  August 25, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00136175
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30