drugset / Trial / NCT00385606

Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC

NCT00385606

Phase 2/3 Completed 400 enrolled National Cancer Institute, Naples
RandomizedFactorialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the tolerability and efficacy of the addition of rofecoxib to first-line chemotherapy, and to evaluate the efficacy of prolonged continuous infusion of gemcitabine in combination with cisplatin in the treatment of patients affected by advanced non-small cell lung cancer.

Timeline

Start
2003-01
Primary completion
2005-12
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1200 mg/m2 Intravenous
Subject rofecoxib Small molecule 50 mg Oral
Background Cisplatin Other / unclassified 80 mg/m2 Intravenous