drugset / Trial / NCT01639521

Gemcitabine Hydrochloride and Cisplatin or High-Dose Methotrexate, Vinblastine, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Urothelial Cancer

NCT01639521

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is about two chemotherapy study drug combinations (regimens) that are used for urothelial (bladder or upper urinary tract) cancer. Both study drug regimens, gemcitabine (gemcitabine hydrochloride) plus cisplatin, and high-dose-intensity MVAC (methotrexate, vinblastine, doxorubicin plus cisplatin), are standard chemotherapy regimens. Both regimens are used to treat people with urothelial cancer that has spread to other organs. Both study drug regimens have been proven to be effective in lowering the risk of the cancer coming back, but it is not known which regimen is the best. This study hopes to learn whether there is a difference in the effectiveness and side effects of these two study drug regimens when they are given to people who have had their urothelial cancer completely removed.

Timeline

Start
2013-05
Primary completion
2013-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified Intravenous
Subject Doxorubicin Other / unclassified Intravenous
Subject Gemcitabine Small molecule Intravenous
Subject Methotrexate Small molecule Intravenous
Subject Vinblastine Small molecule Intravenous
Background Pegfilgrastim Protein / enzyme biologic Subcutaneous