{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Formalin-fixed, paraffin-embedded (FFPE) tumors were collected. The FFPE tumors were to be evaluated for p16 expression using immunohistochemistry staining with antibody. Gene Expression Levels (positive when \\>70% cells stained, otherwise negative) were to be described using frequencies.","groups":[{"description":"Patients were to receive cetuximab 400 mg/m\\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.","id":"OG000","title":"Arm A - Cetuximab"},{"description":"Patients received cetuximab 400 mg/m\\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.","id":"OG001","title":"Arm B - Cetuximab and Sorafenib Tosylate"}],"populationDescription":"Due to an insufficient amount of tumor tissue available to complete planned analysis, this analysis was abandoned.","reportingStatus":"POSTED","timeFrame":"Pre-therapy","title":"Gene Expression Levels","type":"SECONDARY"}