CETUXIMAB PLUS CAPECITABINE AND OXALIPLATIN FOR METASTATIC COLORECTAL CANCER

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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. This is a single-center (NYU) Phase II study of Cetuximab plus biweekly Capecitabine and Oxaliplatin in patients with EGFR-expressing metastatic colorectal cancer. The rationale is that tumors that express EGFR can be inhibited by Cetuximab, which has been shown in trials with irinotecan to provide a modest (10%) response rate. The regimen utilizing Capecitabine and Oxaliplatin (CapOx) has been shown to be similarly effective as the FOLFOX regimens, which are now used as first-line therapy. A combination of the two seems justified, since Cetuximab has a low complication rate and there is a good biological rationale for the addition of the drug improving responses. In this trial the CapOx regimen has been selected to offer improved tolerance and response rate. The primary objective of this study is to estimate its response rate. Secondary objectives include determination of toxicity rates, time to progression and survival for the members of the study. The study itself is open-label, non-randomized and open to individuals with measurable metastatic EGFR-positive colorectal cancer who have not received chemotherapy. The working assumption is that these patients will achieve a 50% response rate, better than either drug alone.