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

• ClinicalTrials.gov Identifier: NCT00136175
• Recruitment Status: Completed
• First Posted: August 26, 2005
• Last Update Posted: January 21, 2015
• Sponsor: University of Michigan Rogel Cancer Center
• Information provided by (Responsible Party): University of Michigan Rogel Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bladder Cancer	Drug: Paclitaxel; Drug: Carboplatin; Drug: Gemcitabine	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 68 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Paclitaxel, Carboplatin and Gemcitabine in Patients With Locally Advanced Transitional Cell Carcinoma of the Bladder
• Study Start Date: November 1999
• Actual Primary Completion Date: December 2005
• Actual Study Completion Date: October 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	Drug: Paclitaxel; Drug: Carboplatin; Drug: Gemcitabine
Experimental: Arm II; Patients with T4 or lymph node positive disease will receive up to 6 cycles of paclitaxel, carboplatin, and gemcitabine.	Drug: Paclitaxel; Drug: Carboplatin; Drug: Gemcitabine

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Percentage of Patients in Arm II that Obtain to Resectable Disease [ Time Frame: 6 Cycles (126 days) of Treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Michigan

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan Rogel Cancer Center

Investigators

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

More Information

• Responsible Party: University of Michigan Rogel Cancer Center
• ClinicalTrials.gov Identifier: NCT00136175
• Other Study ID Numbers: UMCC 9910
• First Posted: August 26, 2005
• Last Update Posted: January 21, 2015
• Last Verified: January 2015

Keywords provided by University of Michigan Rogel Cancer Center:

Neoadjuvant chemotherapy

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Gemcitabine; Paclitaxel; Carboplatin; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs