NCT00716456

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

A Phase I/II Trial of Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Adenocarcinoma

Interventions

Type	Name	Description
DRUG	erlotinib with cetuximab	The phase I portion will accrue as many as 3 cohorts of 3-6 patients; receiving erlotinib 100 mg daily along with escalating doses of cetuximab administered every 2 weeks beginning at 250mg/m2 IV without a loading dose. Subsequent cetuximab dose levels will be 375 mg/m2, and 500 mg/m2, administered IV every 2 weeks. Patients will have baseline CT, labs and ECG done within 2 weeks of study entry. Three patients will be enrolled per dose level. Patients will be monitored for toxicity weekly for the first 5 weeks, and every 2 weeks thereafter. Patients will be monitored for response by CT in the fourth week of combined therapy and every 8 weeks. All patients in this portion of the trial will receive intravenous cetuximab every two weeks at the MTD (to be determined in phase I portion) and daily erlotinib on an outpatient basis and will obtain clinical re-evaluation and radiographic re-imaging on a schedule similar to that followed in the phase I portion

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2008-07-16
• Last updated: 2015-04-30
• Results posted: 2015-04-30

Locations

5 sites across 1 country: United States