Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Tumor response rate
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with colorectal cancer that has spread to the liver and/or lung.
详细描述
OBJECTIVES:
Primary
- Determine the tumor response rate in patients with colorectal cancer and hepatic and/or pulmonary metastases treated with cetuximab and FOLFIRI chemotherapy comprising irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.
Secondary
- Determine the rate of resectability in patients treated with this regimen.
- Determine the overall and disease-free survival of patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
cetuximab, FOLFIRI
干预措施: cetuximab (Biological)
cetuximab, FOLFIRI
干预措施: filgrastim (Biological)
cetuximab, FOLFIRI
干预措施: fluorouracil (Drug)
cetuximab, FOLFIRI
干预措施: irinotecan hydrochloride (Drug)
cetuximab, FOLFIRI
干预措施: leucovorin calcium (Drug)
结局指标
主要结局
Tumor response rate
时间窗: From baseline to end of treatment
次要结局
- Rate of resectability(From baseline to end of treatment)
- Overall and disease-free survival(From baseline to end of treatment)
- Tolerability(From baseline to end of treatment)