Phase III Trial Of Irofulven Vs. 5-Fluorouracil In Patients With Gemcitabine-Refractory Advanced Pancreatic Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Survival of Irofulven vs. 5-FU
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. It is not yet known whether irofulven is effective in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of irofulven with that of fluorouracil in treating patients who have locally advanced or metastatic pancreatic cancer that has not responded to previous treatment with gemcitabine.
详细描述
OBJECTIVES: I. Compare survival of patients with gemcitabine-refractory, advanced pancreatic adenocarcinoma when treated with irofulven vs fluorouracil. II. Compare the objective tumor response rate in patients treated with these regimens. III. Compare the clinical benefit of these regimens as measured by improvement in pain and performance status in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized 2:1 to irofulven and fluorouracil treatment arms. Arm I: Patients receive irofulven IV over 30 minutes on days 1 and 15. Arm II: Patients receive fluorouracil IV continuously on days 1-28. Courses repeat every 28 days.
PROJECTED ACCRUAL: Approximately 350 patients (233 for arm I and 117 for arm II) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
fluorouracil
干预措施: fluorouracil (Drug)
Irofulven
干预措施: Irofulven (Drug)
结局指标
主要结局
Survival of Irofulven vs. 5-FU
时间窗: 28 day cycle or until disease progression
次要结局
- Objective Tumor Response of Irofulven vs. 5-FU and Clinical Benefit of Irofulven vs. 5-FU(28 day cycle or until disease progression)