Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00136175
First received: August 25, 2005
Last updated: January 20, 2015
Last verified: January 2015
  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
Drug: Carboplatin
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Percentage of Patients in Arm I with Complete Pathologic Response [ Time Frame: 3 Cycles (63 days) of Treatment ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients in Arm II that Obtain to Resectable Disease [ Time Frame: 6 Cycles (126 days) of Treatment ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: November 1999
Study Completion Date: October 2007
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Cancer Center
Investigators
Principal Investigator: David C. Smith, MD The University of Michigan Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00136175     History of Changes
Other Study ID Numbers: UMCC 9910
Study First Received: August 25, 2005
Last Updated: January 20, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan Cancer Center:
Neoadjuvant chemotherapy

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Carboplatin
Gemcitabine
Paclitaxel
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on February 25, 2015