drugset / Trial / NCT00216203

Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer

NCT00216203

NaSingle-groupOpen-labelTreatment

Summary

Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.

Timeline

Start
2005-05
Primary completion
2008-12
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2
Subject Pemetrexed Small molecule 600 mg/m2
Subject Pemetrexed Small molecule 750 mg/m2
Subject Pemetrexed Small molecule 900 mg/m2