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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Lung Adenocarcinoma
Interventions
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

Trial Locations (5)

10065

Memorial Sloan-Kettering Cancer Center, New York

10591

Memoral Sloan Kettering Cancer Center at Phelps, Sleepy Hollow

11570

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center, Rockville Centre

11725

Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack

Unknown

Memoral Sloan Kettering Cancer Center, Basking Ridge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00716456 - "Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed Acquired Resistance to Erlotinib" | Biotech Hunter | Biotech Hunter