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

University of Michigan Rogel Cancer Center

Status and phase

Completed

Phase 2

Conditions

Bladder Cancer

Treatments

Drug: Gemcitabine

Drug: Paclitaxel

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00136175

UMCC 9910

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

68 participants in 2 patient groups

Arm I

Experimental group

Description:

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).

Treatment:

Drug: Gemcitabine

Drug: Carboplatin

Drug: Paclitaxel

Arm II

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: Carboplatin

Drug: Paclitaxel