CETUXIMAB PLUS CAPECITABINE AND OXALIPLATIN FOR METASTATIC COLORECTAL CANCER

西妥昔单抗联合卡培他滨和奥沙利铂治疗转移性结直肠癌

• 批准号: 7378335
• 负责人: HOWARD S HOCHSTER
• 金额: $ 2.34万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378335
• 关键词: CETUXIMAB; PLUS; CAPECITABINE; OXALIPLATIN; METASTATIC

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.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项单中心（NYU） II期研究，西妥昔单抗联合双周卡培他滨和奥沙利铂治疗表达egfr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，在伊立替康的试验中显示，西妥昔单抗提供适度（10%）的缓解率。使用卡培他滨和奥沙利铂（CapOx）的方案已被证明与FOLFOX方案相似有效，后者现在被用作一线治疗。这两种药物的结合似乎是合理的，因为西妥昔单抗的并发症发生率低，并且有一个很好的生物学原理来增加药物改善反应。在这项试验中，选择CapOx方案提供了更好的耐受性和反应率。本研究的主要目的是估计其反应率。次要目标包括确定毒性率、进展时间和研究成员的生存。该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。工作假设是这些患者将达到50%的缓解率，比单独使用任何一种药物都好。