NCT00193167已完成2 期
Phase II Study of Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- overall response rate
研究概览
简要总结
This non-randomized phase II study is designed to assess the response rate and toxicity of weekly topotecan as second-line treatment in patients with relapsed or refractory metastatic colorectal cancer.
详细描述
Upon determination of eligibility, patients will be receive:
- Topotecan
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
- •To be included in this study, you must meet the following criteria:
- •Metastatic colorectal cancer
- •One previous chemotherapy for metastatic disease
- •Measurable or evaluable disease
- •Able to perform activities of daily living with assistance
- •Adequate bone marrow, liver, and kidney function
- •All patients must give written informed consent prior to study entry.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Brain or meningeal involvement
- •Serious active infection or underlying medical conditions
- •Other active neoplasms are ineligible
- •Pregnant or lactating
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
overall response rate
次要结局
- median survival
- one year survival
- toxicity
研究者
研究点 (2)
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