drugset / Trial / NCT00716456

Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

NCT00716456

Parallel-groupOpen-labelTreatment

Summary

The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of the phase I portion of this trial is to find out the highest dose of cetuximab that can be taken together with erlotinib. This study will also give an idea of how well cetuximab shrinks lung cancer when given with erlotinib. The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib or gefitinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of this phase is to determine if cetuximab given with erlotinib causes lung cancers to shrink in size.

Timeline

Start
2008-07
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Cetuximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Background Erlotinib Small molecule 100 mg

Indications