Report of first-stage accrual for NCI 5886, a phase II study of erlotinib, carboplatin and paclitaxel as first-line treatment of ovarian cancer

5076 Background: Abnormalities in the EGFR pathway are thought to play a major role in the dysregulated growth of ovarian and related epithelial cancers. The purpose of this study is to determine whether the addition of erlotinib (erl) to the standard first line regimen of paclitaxel (T) and carboplatin (CB) encourages pathologic complete response (pCR) in patients (pts) with ovarian (OC), fallopian tube (FTC) or primary peritoneal (PPC) cancers. Tolerability and toxicity data have been previously reported (ASCO 2005). Correlative studies of EGFR and related pathways are being performed, but data is insufficient currently for presentation. Methods: Pts with a histologic diagnosis of OC, FTC or PPC Stage III or IV with either optimal (≤ 1 cm) or suboptimal residual disease within 12 weeks of initial surgery were eligible for enrollment. Pts received T (175 mg/m2) and CB (AUC 6) every 21 days, along with erl (150 mg) by mouth, daily, continuously, for a planned 6 cycles, after which pts underwent surgical r...