OSI 774 WITH CARBOPLATIN AND PACLITAXEL IN OVARIAN OR PERITONEAL CARCINOMA

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项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口服EGFR酪氨酸激酶抑制剂OSI-774(Tarceva)是否能增强卵巢癌或原发性腹膜癌的病理完全反应。患者将被分成最佳细胞减少组和次佳细胞减少组。Tarceva已经在几个I期和II期研究中进行了研究。由于大多数卵巢癌过度表达EGFR，其毒性特征与其他化疗药物不同。对临床有反应的患者将行腹腔镜术或开腹手术。该方案的毒性也将得到评估。第二个试点目标是确定肿瘤组织预处理中EGFR、截短的EGFR、磷酸化的EGFR和其他下游蛋白的水平是否与实现完全反应相关。对治疗有反应的患者的这些信号蛋白水平的变化也将通过免疫组织化学和重新采样肿瘤的蛋白质分析来评估。这项研究已经开始招收GCRC的受试者。招募工作仍在继续。目前还没有结果的报道。

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.