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

卵巢癌是妇科恶性肿瘤中最常见的死亡原因。对于晚期疾病，积极的手术减积和以铂为基础的联合化疗是标准的治疗方法。由于最近的GOG研究，紫杉醇和顺铂治疗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%的患者表现出完全的病理反应。阿霉素具有广谱的抗肿瘤作用和相应的广泛临床应用。由于潜在的心脏毒性作用，通常必须避免高剂量的这种药物。脂质体包封可增强其药效。1996年4月19日，FDA肿瘤药物咨询委员会建议批准Topotecan用于初始或后续化疗失败的晚期卵巢癌。本研究的目的是比较Doxil/Caelyx与Topotecan HCL在晚期卵巢癌患者中的疗效和安全性。患者将接受为期一年的治疗，要么每28天输注1小时Doxil/Caelyx，要么每21天输注30分钟Topotecan，连续5天。

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 chemotherapy 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 complete 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.