Cetuximab in Treating Patients With Recurrent or Progressive Metastatic Non-Small Cell Lung Cancer
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread.
PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with recurrent or progressive metastatic non-small cell lung cancer.
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Exploratory Pharmacogenomics Study of Erbitux® Monotherapy in Patients With Metastatic Non-Small Cell Lung Carcinoma|
- Tumor response rate [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118118
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Fairooz F. Kabbinavar, MD||Jonsson Comprehensive Cancer Center|