drugset / Trial / NCT01090466

Gemcitabine Hydrochloride, Cisplatin, and Temsirolimus as First-Line Therapy in Treating Patients With Locally Advanced and/or Metastatic Transitional Cell Cancer of the Urothelium

NCT01090466

Phase 1/2 Completed 15 enrolled Cardiff University
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and cisplatin together with temsirolimus may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus given together with gemcitabine hydrochloride and cisplatin as first-line therapy in treating patients with locally advanced and/or metastatic transitional cell cancer of the urothelium.

Timeline

Start
2008-02
Primary completion
2010-01
Completion
2016-03-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified Intravenous
Subject Gemcitabine Small molecule Intravenous
Subject Temsirolimus Small molecule Intravenous