NCT00078975已完成2 期
A Phase II Study of Triapine in Combination With Gemcitabine in Recurrent/Unresectable/Metastatic Pancreatic Carcinoma
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
- 26
- 试验地点
- 4
- 主要终点
- Objective response (complete and partial)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more tumor cells by making them more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with recurrent, unresectable, or metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of 3-AP (Triapine®) and gemcitabine, in terms of complete and partial response and 6-month progression-free disease, in patients with recurrent, unresectable, or metastatic pancreatic cancer.
Secondary
- Determine the objective response rates, median survival, 1-year survival rate, duration of response or stable disease, and progression-free survival of patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
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
Triapine in combination with Gemcitabine
Experimental
干预措施: gemcitabine hydrochloride (Drug)
Triapine in combination with Gemcitabine
Experimental
干预措施: triapine (Drug)
结局指标
主要结局
Objective response (complete and partial)
时间窗: Every 8 weeks for the duration of the trial, an expected average of 5 years
Prolonged stable disease rate
时间窗: Stable disease of 6 or more months
次要结局
- Median survival(For duration of trial, an expected average of 5 years)
- Survival rate at 1 year(1 year)
- Response duration(From date of response until progression)
- Progression-free survival(From date of response until progression or death)
- Safety and tolerability(Up to 1 year)
研究者
研究点 (4)
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