This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Adjuvant therapy using 5-FU/leucovorin combined with radiation has been shown to benefit patients with locally advanced gastric cancer following surgery. Irinotecan in combination with cisplatin has been shown in an NYU study to downstage tumors in a neoadjuvant setting, and when followed with intraperitoneal floxuridine/cisplatin, similar survival with the 5-FU adjuvant therapy trial has been shown. Cetuximab is a monoclonal antibody directed against the EGFR, with activity against EGFR-expressing tumors. Clinical trials have shown that Cetuximab has some activity as a single agent in GI tumors (about 10%) and also appears to restore activity to Irinotecan in some previously refractory patients. Evidence of activity in combination with radiation and with cisplatin has also been reported. This study combines the neoadjuvant approach using Irinotecan in combination with cisplatin after surgery with the standard adjuvant components. The main objective is to determine clinical response in a sample of 30 subjects. Several secondary objectives include safety, assessment of potentially curative surgery following neoadjuvant therapy, and rate of downstaging. Samples will be taken for microarray studies. The endpoint of this study is improvement in response over historical controls, response being determined both by clinical (imaging) criteria and by pathologic findings. A two-stage design will be utilized that takes into account both toxicity and/or relapses.
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