JPRN-UMIN000005816已完成1 期
A phase I/II study of Cisplatin, Amrubicin plus irradiation for Limited disease small cell lung cancer - A phase I/II study of Cisplatin, Amrubicin plus irradiation for Limited disease small cell lung cancer
agasaki Thoracic Oncology Group0 个研究点目标入组 35 人开始时间: 2011年6月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
Eight patients were enrolled at three dose levels. Two of two patients in 30 mg/m2 dose level experienced DLTs. The presentation of DLTs included grade4 neutropenia and leukopenia lasting more than four days. Evaluation of responses were 7 partial response and 1 progressive disease (response rate 87.5%). The MTD of amrubicin and cisplatin were determined as 30 mg/m2 and 60 mg/m2. A dose of 25 mg/m2 amrubicin and cisplatin 60 mg/m2 was recommended in this regimen.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)stage IA (2)accumulated cardiac effusion (3)accumulated pleural effusion (4)Patients with active severe infections (5)Women during pregnancy (6)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
研究者
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