NCT00316420已完成1 期
Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- MTD and DLT for the combination therapy of gemcitabine and capecitabine
研究概览
简要总结
The purpose of this study is to test the effectiveness and safety of the drug combination of gemcitabine and capecitabine (Xeloda) in patients with advanced pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic or unresectable pancreatic cancer
- •No prior chemotherapy except radiation-sensitizing doses of 5-FU
- •No radiotherapy less than 4 weeks prior to the start of the study
排除标准
- •Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU
- •Moderate to severe renal impairment
- •Uncontrolled diabetes
- •Inability to swallow tablets
结局指标
主要结局
MTD and DLT for the combination therapy of gemcitabine and capecitabine
时间窗: January 2010
次要结局
- Tumor Response(January 2010)
研究者
研究点 (2)
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