21
Participants
Start Date
July 31, 2008
Primary Completion Date
May 31, 2011
Study Completion Date
May 31, 2011
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
Memorial Sloan-Kettering Cancer Center, New York
Memoral Sloan Kettering Cancer Center at Phelps, Sleepy Hollow
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center, Rockville Centre
Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack
Memoral Sloan Kettering Cancer Center, Basking Ridge
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER