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Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Bladder Cancer

Urinary Bladder Neoplasms Clinical Trial

Official title:
Phase II Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Urothelial Cancer

Clinical Trial Summary

This trial is for people with bladder cancer that has spread. The purpose of this research study is to see if the chemotherapy combination of gemcitabine and cisplatin plus paclitaxel is safe and effective treatment for bladder cancer.

Paclitaxel, gemcitabine and cisplatin have all been approved by the United States Food and Drug Administration (FDA). Gemcitabine and cisplatin is a standard treatment for bladder cancer. There have been studies that show that paclitaxel and cisplatin have antitumor activity in bladder cancer. European researchers studied paclitaxel, gemcitabine and cisplatin (same drug combination in this trial) and found that the combination provided good disease control and was well tolerated. Investigators are studying the same drug combination, but at different dosages and schedule.

Clinical Trial Description

The rationale of the present study is to develop a combination based on the pharmacokinetics and mechanisms of action of the agents paclitaxel plus gemcitabine and cisplatin, which are all known active agents in urothelial tumors. Gemcitabine may be synergistic with DNA-damaging drugs such as paclitaxel and cisplatin because it can antagonize DNA repair. Investigators will investigate the combination in this Phase II study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02560038
Study type Interventional
Source The University of Texas Health Science Center, Houston
Contact
Status Terminated
Phase Phase 2
Start date October 2015
Completion date September 14, 2017
View Details
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