Phase Ib/IIa Study of an Anti-Epidermal Growth Factor Receptor (EGFr) Antibody Cetuximab in Combination With Carboplatin-Paclitaxel in Patients With Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the safety profile of cetuximab when used in combination with paclitaxel and carboplatin
8 Weeks
Yes
E-mail: ClinicalTrials@ ImClone.com
Study Chair
ImClone LLC
United States: Food and Drug Administration
CP02-9932
NCT00034541
December 2000
May 2003
Name | Location |
---|---|
ImClone Investigational Site | Denver, Colorado 80262 |
ImClone Investigational Site | Greenwich, Connecticut 06830 |
ImClone Investigational Site | Indianapolis, Indiana 46202 |