CLINICAL TRIAL: OSI 774 WITH CARBOPLATIN AND PACLITAXEL IN OVARIAN OR PERITONEAL

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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.