17
Participants
Start Date
May 31, 2005
Primary Completion Date
July 31, 2008
Study Completion Date
November 30, 2008
cetuximab
400 mg/m2 iv week 1, then 250 mg/m2 weekly thereafter, starting on day 1 and continuing until progressive disease, excessive toxicity or removal from study for other reasons listed in the protocol.
celecoxib
200 mg po BID starting on day 1 and continuing until progressive disease, excessive toxicity or removal from study for other reasons listed in the protocol.
proteomic profiling
Serum samples obtained as above will be analyzed by proteomic analysis in order to determine biomarkers of treatment response and toxicity prediction. We will use LC-MS-MS or MALDITOF mass spectrometry.
immunohistochemistry staining method
phospho-EGFR levels using western blots of tissue extracts and immunohistochemistry on frozen and (if no other option available, paraffinembedded tissue sections).
laboratory biomarker analysis
Serum samples obtained as above will be analyzed by proteomic analysis in order to determine biomarkers of treatment response and toxicity prediction.
mass spectrometry
We will use LC-MS-MS or MALDITOF mass spectrometry. Before any tissues are received, the drug of interest is evaluated via MALDI mass spectrometry on a MDS/Sciex QStar QqTOF mass spectrometer.
Vanderbilt-Ingram Cancer Center, Nashville
National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER