CETUXIMAB PLUS CAPECITABINE AND OXALIPLATIN FOR METASTATIC COLORECTAL CANCER

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项单中心(NYU)II期研究，西妥昔单抗联合两周一次的卡培他滨和奥沙利铂治疗EGFR表达的转移性结直肠癌患者。其基本原理是，表达EGFR的肿瘤可以被西妥昔单抗抑制，西妥昔单抗已经在伊立替康的试验中显示出适度的(10%)应答率。使用卡培他滨和奥沙利铂(CapOx)的方案已被证明与FOLFOX方案同样有效，后者现在被用作一线治疗。两者的结合似乎是合理的，因为西妥昔单抗的并发症发生率很低，而且添加这种改善反应的药物有很好的生物学基础。在这项试验中，选择了CapOx方案来提供更好的耐受性和应答率。这项研究的主要目标是估计其应答率。次要目标包括确定毒性比率、进展时间和研究成员的存活率。这项研究本身是开放标签的，非随机的，对未接受化疗的可测量的转移性EGFR阳性结直肠癌患者开放。可行的假设是，这些患者将达到50%的应答率，比单独使用任何一种药物都要好。

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.