Status:
COMPLETED
Paclitaxel, Carboplatin and Gemcitabine in the Treatment of Patients With Advanced Transitional Cell Cancer of the Bladder
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 stra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00136175
Start Date
November 1 1999
End Date
October 1 2007
Last Update
January 21 2015
Active Locations (1)
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1
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109