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

NCT00136175 | Completed Phase 2 DMC

• 1 other identifier: UMCC 9910
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients in Arm I with Complete Pathologic Response

  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.

  3 Cycles (63 days) of Treatment

• Percentage of Patients in Arm II that Obtain to Resectable Disease

  6 Cycles (126 days) of Treatment

Study Arms (2)

Arm I

EXPERIMENTAL

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

Arm II

EXPERIMENTAL

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

Interventions

Paclitaxel DRUG

Arm I; Arm II

Carboplatin DRUG

Arm I; Arm II

Gemcitabine DRUG

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Paclitaxel; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• David C. Smith, MD

  The University of Michigan Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 26, 2005
• Study Start: November 1, 1999
• Primary Completion: December 1, 2005
• Study Completion: October 1, 2007
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

US (1)