CONCURRENT CHEMOTHERAPY + CETUXIMAB VS CHEMOTHERAPY IN ADVANCED NSCLC

西妥昔单抗同步化疗与晚期 NSCLC 化疗的对比

• 批准号: 7376345
• 负责人: RAJA MUDAD
• 金额: $ 0.12万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376345
• 关键词: CONCURRENT; CHEMOTHERAPY; CETUXIMAB; VS; ADVANCED

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. The objectives of this study are to 1) select a regimen based on overall survival via a Phase II selection design of chemotherapy in conjunction with cetuximab (concurrent vs sequential) for Phase III testing against chemotherapy alone in stage IIIB & stage IV NSCLC, 2) evaluate response rates (confirmed & unconfirmed, complete & partial) of patients with selected stage IIIB & stage IV NSCLC treated with paclitaxel & carboplatin with concurrent cetuximab or paclitaxel & carboplatin followed by cetuximab and 3) evaluate the toxicities of the 2 treatment regimens in patients with selected stage IIIB & stage IV NSCLC. The secondary objectives are to conduct explatory molecular correlative studies of the EGFR-HER signaling pathways activated phosphoproteins, oncogenic mutations & rates of proliferation & apoptosis in patients tissues & evaluate EGFR polymorphisms as a potential correlate for response to cetuximab.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究的目的是：1）通过化疗联合西妥昔单抗的II期选择设计，基于总生存期选择方案（同步vs序贯）在IIIB期和IV期NSCLC中针对单独化疗的III期试验，2）评价缓解率（已确认和未确认，选择IIIB期和IV期NSCLC患者，接受紫杉醇和卡铂联合西妥昔单抗或紫杉醇和卡铂治疗，卡铂，然后是西妥昔单抗，和3）在患有选定的IIIB期和IV期NSCLC的患者中评价2种治疗方案的毒性。次要目的是对EGFR-HER信号通路激活的磷蛋白、致癌突变以及患者组织中的增殖和凋亡率进行解释性分子相关性研究，并评估EGFR多态性作为西妥昔单抗应答的潜在相关性。