Efficacy and Safety of Second-line Combination Chemotherapy With Avastin in Patients With Metastatic Colorectal Cancer Who Have Received First-line Chemotherapy Plus Avastin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
Bevacizumab beyond progression has been proven to be safe in the community setting (BRiTE) and in the post-marketing study (BEAT), and confirmed its efficacy and safety in the first line with all regimens of chemotherapy. A total of 1,953 patients were treated in BRiTE. At median follow-up of 17.5 mo, there were 1,369 1st PD and 839 deaths. Among patients with 1st PD, 65.2% received any 2nd-line chemotherapy, 34.8% received cetuximab, and 53.8% received BBP. In a multivariate analysis, Bevacizumab beyond first progression and exposure to any 2nd-line chemotherapy were independently associated with increased overall survival (both p < 0.0001). Bevacizumab beyond progression appears to be associated with longer overall in BRiTE.
The investigators planned a prospective study to prove this phenomenon of bevacizumab beyond progression.
详细描述
Patients should have been treated with bevacizumab plus chemotherapy as a 1st line treatment, and after 1st progression, these patients will be accrued in this study of bevacizumab plus chemotherapy as a 2nd line treatment, and the combined chemotherapy will be chosen by physician's decision in consider with previous chemotherapy.
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
- •Histologically documented colorectal adenocarcinoma
- •Progression during first-line bevacizumab containing chemotherapy within 3 months
- •No serious toxicity to bevacizumab of 1st line treatment
- •Unresectable metastases
- •Uni-dimensional measurable lesion(s) by RECIST
- •Age over 18 years old
- •Adequate organ functions by clinical laboratory exams
排除标准
- •Other tumor type than adenocarcinoma
- •CNS metastases
- •GI bleeding
- •Hypersensitivity to any of chemotherapeutic agents
- •Prior use of cetuximab or other targeted agents other than bevacizumab
- •Major surgery within 6 weeks
- •Other serious illness
研究组 & 干预措施
Bevacizumab
Bevacizumab continuation plus chemotherapy in patients who have failed previous bevacizumab plus other chemotherapy
干预措施: Bevacizumab (Avastin) (Drug)
结局指标
主要结局
Progression free survival
时间窗: 6 weeks
次要结局
- Overall survival(6 weeks)
- Toxicity profiles(2 or 3 weeks)
研究者
Tae Won Kim
Professor
Asan Medical Center