drugset / Trial / NCT00101842

Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer

NCT00101842

Phase 1/2 Completed 61 enrolled Eli Lilly and Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated with the combination of these drugs; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make your tumor smaller or disappear, and for how long.

Timeline

Start
2004-12
Primary completion
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified
Subject Gemcitabine Small molecule
Subject Pemetrexed Small molecule