Phase Ib, IIa Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer
The primary objective of this study is to evaluate the safety profile of Cetuximab when used
in combination with gemcitabine and carboplatin in patients with EGFr positive,
chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC).
Also, the study will determine the response rate in patients with EGFr positive
chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC) treated with Cetuximab in
combination with gemcitabine and carboplatin as well as determine the time to progression in
patients with EGFr positive chemotherapy-naive, stage IV NSCLC treated with Cetuximab in
combination with gemcitabine and carboplatin.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the tumor response of cetuximab in combination with gemcitabine and carboplatin in patients with EGFr positive, chemotherapy-naive, Stage IV non-small cell lung cancer.
3-week cycles with evaluation after every 2 cycles until disease progression or unacceptable toxicity
Yes
Francisco Robert, M.D.
Principal Investigator
University of Alabama at Birmingham
United States: Institutional Review Board
X010524006
NCT01004731
June 2001
January 2006
Name | Location |
---|---|
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |