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

Sponsored by:	University of Michigan
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00136175

Purpose

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

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Paclitaxel Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Phase II Trial of Paclitaxel, Carboplatin and Gemcitabine in Patients With Locally Advanced Transitional Cell Carcinoma of the Bladder

Further study details as provided by University of Michigan:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	87
Study Start Date:	November 1999

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136175

Locations

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

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator:

David C. Smith, MD

The University of Michigan Comprehensive Cancer Center

More Information

No publications provided

Study ID Numbers:	UMCC 9910
Study First Received:	August 25, 2005
Last Updated:	January 19, 2006
ClinicalTrials.gov Identifier:	NCT00136175 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

Neoadjuvant chemotherapy

Study placed in the following topic categories:

Antimetabolites
Urinary Tract Neoplasm
Cystocele
Immunologic Factors
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Antimitotic Agents
Carboplatin
Carcinoma, Transitional Cell
Urologic Neoplasms
Immunosuppressive Agents

Antiviral Agents
Carcinoma
Radiation-Sensitizing Agents
Urologic Diseases
Paclitaxel
Tubulin Modulators
Bladder Neoplasm
Gemcitabine
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial
Transitional Cell Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Neoplasms by Site
Urologic Diseases
Therapeutic Uses
Gemcitabine
Neoplasms by Histologic Type

Mitosis Modulators
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009