OSI 774 WITH CARBOPLATIN AND PACLITAXEL IN OVARIAN OR PERITONEAL CARCINOMA

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。本研究的主要目的是确定在紫杉醇和卡铂的标准组合中加入OSI-774（特罗凯）（一种EGFR酪氨酸激酶的口服活性抑制剂）是否能增强卵巢癌或原发性腹膜癌的病理完全缓解。患者将被分层为最佳细胞减灭组和次佳细胞减灭组。Tarceva已在多项I期和II期研究中进行了研究。其毒性不同于其他化疗药物，因为大多数卵巢癌都过表达EGFR。临床应答患者将接受腹腔镜检查或剖腹手术。还将评价该方案的毒性。次要试验性目的是确定肿瘤组织预处理中EGFR、截短EGFR、磷酸化EGFR和其他下游蛋白质的水平是否与实现完全缓解相关。还将通过免疫组织化学和western分析通过肿瘤的复发来评估对治疗有反应的那些人中这些信号传导蛋白水平的变化。本研究已开始招募GCRC受试者。招募工作仍在继续。目前尚未报告结果。

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 main objectives of this study are to determine if the addition of OSI-774 (Tarceva), which is an orally active inhibitor of EGFR tyrosine kinase, to a standard combination of paclitaxel and carboplatin enhances pathologic complete responses in ovarian or primary peritoneal carcinoma. Patients will be stratified into a group with optimal cytoreduction and a group with suboptimal cytoreduction. Tarceva has been studied in several phase I and II studies. The toxicity profile is different from other chemotherapeutic agents, since most ovarian cancers overexpress EGFR. Laparoscopy or laparotomy will be performed in patients with clinical response. The toxicity of the regimen will also be evaluated. Secondary pilot objectives are to establish if levels of EGFR, truncated EGFR, phosphorylated EGFR and other downstream proteins in tumor tissue pretreatment correlate with achievement of complete response. Change in levels of these signaling proteins in those who respond to treatment will also be evaluated by immunohistochemistry and western analysis by resampling of the tumor. This study has begun enrolling subjects on the GCRC. Recruitment continues. No results have been reported yet.