An Exploratory Pharmacogenomics Study of Erbitux® Monotherapy in Patients With Metastatic Non-Small Cell Lung Carcinoma
- Determine whether expression of Calgranulin B, E-Cadherin, S100P, FXYD domain
containing 3, Cathepsin B, and/or Serpin E2 can predict response to cetuximab in
patients with recurrent or progressive metastatic non-small cell lung cancer.
- Determine whether additional genes can be identified, using microarray analysis and
panels of candidate genes for involvement in cancer, that are predictive of response to
this drug in these patients.
- Determine whether proteins discovered in serum can predict tumor response to this drug
in these patients.
- Correlate CA repeats, single nucleotide polymorphisms, or mutations of genes within the
epidermal growth factor receptor pathway with response to this drug in these patients.
OUTLINE: This is an open-label, non-randomized, multicenter study.
Patients receive cetuximab IV over 1-2 hours once weekly for 8 weeks. Courses repeat every 8
weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for at least 30 days, every 3
months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate
Fairooz F. Kabbinavar, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|