drugset / Trial / NCT02560038

Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Bladder Cancer

NCT02560038 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-10
Primary completion
2017-09-14
Completion
2017-09-14

Outcome

Outcome not reported

Stopped (Enrollment): “slow enrollment; resource re-allocation”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 70 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous