A Phase II Trial of Carboplatin, Ixabepilone and Cetuximab in Chemotherapy Naive Advanced Non-Small Cell Lung Cancer
- To estimate the disease-control rate in patients with advanced chemotherapy-naive
non-small cell lung cancer after 2 courses of carboplatin, ixabepilone, and cetuximab.
- To estimate the progression-free survival of patients treated with this regimen.
- To estimate the overall survival of patients treated with this regimen.
- To estimate the toxicity of this regimen in these patients.
- To determine the potential predictive marker of efficacy of ixabepilone and cetuximab.
- To investigate the prevalence of cetuximab IgE antibody, and the rate of cetuximab
hypersensitivity reactions in patients without evidence of cetuximab IgE antibodies.
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and
cetuximab IV over 1-2 hours on days 1, 8 and 15. Treatment repeats every 21 days for up to
2-4 courses in the absence of disease progression or unacceptable toxicity. Treatment
modifications may apply according to response.
Tumor tissue and blood samples are collected for further analysis.
After completion of study therapy, patients are followed periodically.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-control rate after 2 courses of carboplatin, cetuximab, and ixabepilone
Disease control rate will be defined as patients experiencing a complete or partial response or stable disease (radiographic response) measured by RECIST criteria.
Thomas E. Stinchcombe, MD
UNC Lineberger Comprehensive Cancer Center
United States: Food and Drug Administration