NCT00089128终止2 期
Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Response Proportion
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced or metastatic bladder cancer.
详细描述
OBJECTIVES:
Primary
- Determine response in patients with locally advanced or metastatic transitional cell carcinoma of the bladder treated with gemcitabine and irinotecan.
Secondary
- Determine the duration of response in patients treated with this regimen.
- Determine the tolerance to and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gemcitabine and Irnotecan
Experimental
干预措施: gemcitabine hydrochloride (Drug)
Gemcitabine and Irnotecan
Experimental
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Response Proportion
时间窗: From registration until time of complete response or partial response
次要结局
- Duration of Response(From registration until disease progression among patients who had at least a partial response.)
- Progression-free Survival(Time between registration and disease progression or death, whichever comes first.)
- Frequency of Adverse Events as Assessed by NCI CTC Version 2.0(From the day of first dose until the end of study, an average of 6 months)
研究者
研究点 (1)
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