Paclitaxel, Carboplatin and Gemcitabine in the Treatment of Patients With Advanced Transitional Cell Cancer of the Bladder
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|ClinicalTrials.gov Identifier: NCT00136175|
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : January 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Paclitaxel Drug: Carboplatin Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
Experimental: Arm II
Patients with T4 or lymph node positive disease will receive up to 6 cycles of paclitaxel, carboplatin, and gemcitabine.
- 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.
- Percentage of Patients in Arm II that Obtain to Resectable Disease [ Time Frame: 6 Cycles (126 days) of Treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136175
|United States, Michigan|
|The University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||David C. Smith, MD||The University of Michigan Comprehensive Cancer Center|