CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. There are approximately 43,000 cases of head and neck squamous cell carcinoma diagnosed annually in the United States. Approximately two thirds of these patients present with advanced disease (Stage III or IV). Successful nonoperative treatment strategies have advanced considerably over recent years through the refinement of intensified radiation fractionation schedules and/or the use of combination chemoradiation approaches. Nonetheless, for many patients with advanced but resectable squamous cell carcinoma of the head and neck, surgical resection followed by postoperative radiation therapy remains a common treatment approach. Despite aggressive surgery and adjuvant radiation, many patients still succumb to locoregional disease recurrence. Distant metastases (most commonly to the lungs) can also occur in advanced head and neck cancer patients, and the frequency of this event is increased in patients who suffer locoregional disease recurrence following definitive therapy. Published reports suggest that approximately one quarter to one third of advanced head and neck cancer patients treated with surgery and postoperative radiation therapy experience locoregional disease recurrence. Efforts to diminish these recurrence rates have focused primarily on combined chemoradiation in the postoperative setting. Primary Objective: To evaluate, using a random assignment phase II design, two treatment regimens that utilize the EGFR inhibitor C225 in combination with chemoradiation in high-risk postoperative head and neck patients. This trial is designed to determine if either regimen is promising enough to be pursued in a pursued in a subsequent phase III study. This decision will be primarily based on whether there is improvement in disease-free survival relative to the RTOG database of similar patients treated with chemoradiation in the completed intergroup trial RTOG 9501. Secondary Objective: 1) To determine whether each of the treatment regimens can be delivered safely and successfully following surgical resection for advanced head and neck cancer. 2) To estimate the locoregional control and overall survival rates for patients treated with the each regimen. 3) To examine the correlation between EGFR (total and phosphorylated), pMAPK, pAKT, Stat-3, Ki-67, COX-2, and cyclin B1 expression with the ultimate treatment outcome.