NCT00401635已完成2 期
Phase II Multicentered Study of First-Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With the Combination of Carboplatin and Liposomal Doxorubicin
National Cancer Institute, Naples8 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2002年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- Objective response rate (complete and partial responses)
研究概览
简要总结
The purpose of this study is to evaluate activity and toxicity of the combination of carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or recurrent endometrial carcinoma.
详细描述
Treatment is planned with carboplatin AUC 5 given IV on day 1 and liposomal doxorubicin 40 mg/m2 given IV on day 1, with treatment repeated every 28 days. Delays in treatment administration and dose reductions have been planned according to toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cytologic / histologic diagnosis of endometrial carcinoma
- •Indication for chemotherapy
- •Age 75 years or less
- •Life expectancy of at least 3 months
- •Measurable disease > 1 cm
排除标准
- •Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
- •Performance status (ECOG) > 2
- •Previous chemotherapy treatment
- •Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia)
- •Leukocytes < 4000/mm3, platelets < 100000/mm3
- •Impaired renal function (creatinine > o = 1.25 times the upper normal limit) or liver function (SGOT or SGPT > o = 1.25 times the upper normal limit)
- •Present or suspected hemorrhagic syndromes
- •Uncooperative and/or unreliable patients
- •Patient's inability to access the center
- •Refusal of informed consent
结局指标
主要结局
Objective response rate (complete and partial responses)
Toxicity
次要结局
未报告次要终点
研究者
研究点 (8)
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