Oxaliplatin, Irinotecan, and Capecitabine as a Combination Regimen for First-Line Treatment of Advanced or Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- capecitabine + oxaliplatin + irinotecan dose finding
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with oxaliplatin and irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable advanced or metastatic colorectal cancer. (Phase I)
- Determine the efficacy of this regimen in these patients. (Phase II)
Secondary
- Determine the tolerability of this regimen in these patients. (Phase II)
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 70 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
Arm A
Oxaliplatin, Irinotecan, and Capecitabine
干预措施: Capecitabine (Drug)
Arm A
Oxaliplatin, Irinotecan, and Capecitabine
干预措施: irinotecan hydrochloride (Drug)
Arm A
Oxaliplatin, Irinotecan, and Capecitabine
干预措施: oxaliplatin (Drug)
结局指标
主要结局
capecitabine + oxaliplatin + irinotecan dose finding
时间窗: 30 days
Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable advanced or metastatic colorectal cancer. (Phase I)
Efficacy of Oxaliplatin, Irinotecan, and Capecitabine
时间窗: 2 months
Determine the efficacy of this regimen in these patients (Phase II)
次要结局
- Objective response (CR or PR) as measured after completion of study treatment(2 months)
- Adverse events as measured after completion of study treatment(2 months)
- Time to progression(life-long)
- Time to treatment failure as measured after completion of study treatment(life-long)
- Overall survival(life-long)