SEQU3049:STUDY OF DOXIL VS TOPOTECAN HCL IN PATIENTS W/ OVARIAN CANCE

卵巢癌是妇科恶性肿瘤最常见的死亡原因。对于晚期疾病，积极的手术清除，然后以铂为基础的联合化疗是护理的标准。根据GOG最近的研究，紫杉醇和顺铂被认为是晚期卵巢癌治疗的新标准。虽然大多数患者表现出完全的临床反应，但只有50%的患者有明显的病理反应。阿霉素具有广泛的抗肿瘤作用，临床应用也相应广泛。通常必须避免大剂量的这种药物，因为它具有潜在的心脏毒性作用。脂质体包封会增强其疗效。1996年4月19日，FDA肿瘤学药物咨询委员会建议在初次或后续化疗失败后批准拓朴替康用于晚期卵巢癌。本研究的目的是比较Doxil/Caelyx与盐酸拓扑替康治疗晚期卵巢癌的疗效和安全性。患者将接受长达一年的治疗，要么每28天一小时输注Doxil/Caelyx，要么每21天连续5天输注30分钟的拓扑替康。

Ovarian cancer is the most frequent cause of death due to gynecologic malignancies. For advanced stage disease, aggressive surgical debulking followed by platinum-based combination chemoterhapy is the standard of care. As a result of recent GOG studies, paclitaxel and cisplatin therapy is considered to be the new standard of care in advanced ovarian cancer. Although the majority of patients demonstrate a complete clinical response, only 50% have a compelte pathological response. Doxorubicin has a broad spectrum of antineoplastic action and a correspondingly widespread degree of clinical use. High doses of this drug must generally be avoided because of potential cardiotoxic effects. A liposomal encapsulation would enhance its efficacy. On 4/19/96, FDA's Oncology Drug Advisory Committee recommended approval of Topotecan for advanced ovarian cancer after failure of initial or subsequent chemotherapy. The objective of this study is to compare the efficacy and safety of Doxil/Caelyx versus Topotecan HCL in advanced ovarian cancer patients. Patients will be treated for up to one year with either a one-hour infusion of Doxil/Caelyx every 28 days or Topotecan as a 30-minute infusion for five consecutive days every 21 days.