An Open Label Study to Assess the Effect of FOLFIRI Plus Avastin and Cetuximab on Progression-free Survival in Patients With Previously Untreated Metastatic Colorectal Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Progression-free survival
研究概览
简要总结
This single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.
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
- •adult patients, >=18 years of age;
- •colorectal cancer;
- •advanced or recurrent disease;
- •>=1 measurable lesion;
- •>=6 months since prior adjuvant therapy, and >=4 weeks since prior radiotherapy.
排除标准
- •previous treatment for colorectal cancer;
- •significant history of cardiac disease in past 6 months;
- •other invasive malignancy within past 5 years, except for nonmelanoma skin cancer, and successfully treated cervical or prostate cancer.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: Irinotecan (Drug)
1
干预措施: Leucovorin (Drug)
1
干预措施: 5 FU (Drug)
1
干预措施: Cetuximab (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 12 months
次要结局
- Objective response rate, rate of resection of hepatic metastases, overall survival.(Event driven)
- AEs, laboratory parameters.(Throughout study)