JPRN-UMIN000006019已完成1 期
Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer - Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer
Tokai University School of Medicine Division of Breast and Endocrine Surgery Department of Surgery0 个研究点目标入组 47 人开始时间: 2011年7月22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
- 47
研究概览
简要总结
In 1000mg/m2 of gemcitabine dose, DLT was observed in one case of 6 patienrs. This DLT was grade 4 neutropenia. And in 1250mg/m2 of gemcitabine dose, no DLT was observed. Finaly, recomended dose will be 1250mg/m2 of gemcitabine.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •Prior administration of gemcitabine Pulmonary fibrosis or pneumonitis Abnormal cardiac function, myocardial infarction within 6 months Body cavity fluid which needs to treatment Active infection Severe complicated situation Severe drug allergic reaction Serious psychiatric illness After bone marrow transplantation After stem cell transplantation Symptomatic systemic brain metastasis Double chemotherapy Pregnancy, breast feeding, suspected pregnancy
研究者
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