Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 96
- 主要终点
- 6-month survival rate
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent cancer of the esophagus.
详细描述
OBJECTIVES:
- Determine the 6-month survival rate of patients with metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction treated with gemcitabine and irinotecan.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.
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
Gemcitabine + Irinotecan
Gemcitabine 1000mg/m2 IV over 30 min on Days 1,8 q21days; Irinotecan 100mg/m2 IV over 90 min on Days 1,8 q21days
干预措施: gemcitabine hydrochloride (Drug)
Gemcitabine + Irinotecan
Gemcitabine 1000mg/m2 IV over 30 min on Days 1,8 q21days; Irinotecan 100mg/m2 IV over 90 min on Days 1,8 q21days
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
6-month survival rate
时间窗: 6 months after registration
To assess the six-month survival rate in patients with esophageal cancer treated with a gemcitabine-irinotecan combination chemotherapy regimen.
次要结局
- Toxicities(Week 1 and Week 2 of each cycle)