The study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for efficacy and safety throughout the duration of the study.
The study will enroll approximately 33 chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive 3-week cycles of therapy with the exception of the initial cycle where the patients will receive 4 cycles of therapy. Patients will be enrolled after EGFr expression is confirmed and the study inclusion and exclusion criteria are met. An initial dose of cetuximab will be administered prior to the initiation of chemotherapy. Thereafter, cetuximab will be infused weekly. On the first day of each cycle, a paclitaxel infusion will be administered post completion of the cetuximab infusion, immediately followed by a carboplatin infusion. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for a tumor response at the end of every two cycles of therapy and evaluated for safety throughout the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
400 mg/m2 i.v. over 120 minutes
225 mg/m2, infusion
30-minute AUC = 6, infusion.
ImClone Investigational Site
Denver, Colorado, United States
ImClone Investigational Site
Greenwich, Connecticut, United States
ImClone Investigational Site
Indianapolis, Indiana, United States
Assess the safety profile of cetuximab when used in combination with paclitaxel and carboplatin
Time frame: 8 Weeks
Antitumor activity
Time frame: 8 Weeks
Effect of cetuximab on the pharmacokinetics of paclitaxel and carboplatin
Time frame: 8 Weeks
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