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

SEQU3049：DOXIL 与拓扑替康 HCL 在卵巢癌患者中的研究

• 批准号: 6309599
• 负责人: PATRICIA S BRALY
• 金额: $ 1.12万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6309599
• 关键词: clinical research; doxorubicin; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; ovary neoplasms; topotecan

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.

卵巢癌是妇科恶性肿瘤最常见的死亡原因。 对于晚期疾病，积极的手术减积，然后是铂类联合化疗是治疗标准。 作为最近GOG研究的结果，紫杉醇和顺铂治疗被认为是晚期卵巢癌的新标准治疗。虽然大多数患者表现出完全的临床反应，但只有50%的患者具有完全的病理学反应。 多柔比星具有广谱的抗肿瘤作用和相应的广泛的临床应用。 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。 脂质体包封将增强其功效。 1996年4月19日，FDA的肿瘤药物咨询委员会建议批准托泊替康用于初始或后续化疗失败后的晚期卵巢癌。 本研究的目的是比较Doxil/Caelyx与盐酸拓扑替康在晚期卵巢癌患者中的疗效和安全性。 患者将接受长达一年的Doxil/Caelyx输注1小时，每28天一次，或托泊替康输注30分钟，连续5天，每21天一次。