Conditions: Lung Adenocarcinoma
Keywords: MAB C225(CETUXIMAB)(ANTI-EGFR) OSI-774, TARCEVA (ERLOTINIB) Lung Adenocarcinoma Lung cancer
Allocation:  | Intervention model: PARALLEL
Enrollment: 21
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: In the phase I portion, patients will be enrolled in cohorts of 3-6 patients;receiving daily erlotinib 100 mg along with cetuximab given every 2 weeks beginning at 250mg/m2 IV. Following the initial dose, for dose levels 1 and 2 (250 mg/m2 and 375 mg/m2) patients will receive treatment every 2 weeks with cetuximab over 60 minutes. For dose level 3 (500 mg/m2) patients will receive treatment every 2 weeks with cetuximab over 120 minutes. The infusion rate of cetuximab should never exceed 10 mg/minute (5 mL/min). The dose may subsequently be reduced for individual patients, depending on a patient's toxicity.

Interventions: intervention 1: erlotinib with cetuximab
Intervention descriptions: intervention 1: 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

Protocol document: