Paclitaxel, Carboplatin and Gemcitabine in the Treatment of Patients With Advanced Transitional Cell Cancer of the Bladder

NCT ID: NCT00136175

Last Updated: 2015-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30
• Study Completion Date: 2007-10-31

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Arm II

Patients with T4 or lymph node positive disease will receive up to 6 cycles of paclitaxel, carboplatin, and gemcitabine.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Interventions

Paclitaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David C. Smith, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Michigan Comprehensive Cancer Center

Locations

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

UMCC 9910

Identifier Type: -

Identifier Source: org_study_id