NCT00053222已完成2 期
A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 11
- 主要终点
- Objective response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have locally advanced or metastatic pancreatic cancer that has not responded to gemcitabine.
详细描述
OBJECTIVES:
- Determine the objective response rate to arsenic trioxide in patients with pancreatic cancer who have progressed after first-line treatment with a gemcitabine-containing regimen when treated with arsenic trioxide.
- Determine the toxicity of this drug in these patients.
- Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive arsenic trioxide IV over 1 hour on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
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 —（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
Arm A
Experimental
Arsenic trioxide (0.3 mg/kg/day iv for 5 days every 28 days)
干预措施: arsenic trioxide (Drug)
结局指标
主要结局
Objective response
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (11)
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