Dataset from A Phase 3, Randomized, Open-Label, Comparative Study of CAELYX Versus Paclitaxel HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

The objective of this study is to compare the efficacy and safety of CAELYX versus Paclitaxel HCl in patients with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy. The primary endpoint is time to progression (TTP) following treatment with either CAELYX or Paclitaxel HCl; the secondary endpoints are response rates, time to response, duration of response,quality of life assessment, and survival following treatment with either CAELYX or Paclitaxel HCl. Up to a total of 438 protocol-eligible patients with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy will be enrolled in order to obtain 350 evaluable patients.

本研究旨在对比CAELYX与盐酸紫杉醇（Paclitaxel HCl）在一线铂类化疗失败的上皮性卵巢癌患者中的疗效与安全性。本研究的主要终点为接受CAELYX或盐酸紫杉醇治疗后的疾病进展时间（TTP）；次要终点包括缓解率、至缓解时间、缓解持续时间、生活质量评估以及接受上述两种药物治疗后的生存情况。本研究计划入组至多438名符合方案要求的一线铂类化疗失败上皮性卵巢癌患者，以获取350名可评估患者。