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Phase II Trial of Paclitaxel, Carboplatin and Gemcitabine in Patients With Locally Advanced Transitional Cell Carcinoma of the Bladder


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

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.


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.

Exclusion Criteria:

- Patients may not have had prior systemic or intra-arterial chemotherapy and no prior
radiotherapy. (Patients may have received intravesicular chemotherapy.)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

David C. Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Michigan Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 9910

NCT ID:

NCT00136175

Start Date:

November 1999

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Neoadjuvant chemotherapy
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell

Name

Location
The University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109