Randomized PhIII Trial of Cetuximab, Bevacizumab & Biweekly Infusional 5FU/Leucovorin (FOLF-CB) vs. Oxaliplatin, Bevacizumab, & Biweekly Infusional 5FU/Leucovorin (Bev-FOLFOX) in First Line Treatment of Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 247
- 试验地点
- 78
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer.
详细描述
This is a Phase III, open label, nonblinded study. A total of 240 eligible patients will be randomized on a 1:1 basis to either treatment Arm.
In this trial, we will compare the efficacy, safety, and tolerability of this novel combination of biweekly infusional 5-FU/leucovorin plus cetuximab and bevacizumab (FOLF-CB) to the current standard of care, biweekly infusional 5-FU/leucovorin plus oxaliplatin and bevacizumab (Bev-FOLFOX). For practical purposes, this study will be a head to head comparison of oxaliplatin versus cetuximab, since the other components of both regimens will be the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
Bev-FOLFOX
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
干预措施: Bevacizumab (Drug)
Bev-FOLFOX
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
干预措施: Oxaliplatin (Drug)
Bev-FOLFOX
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
干预措施: Leucovorin (Drug)
Bev-FOLFOX
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
干预措施: Fluorouracil (Drug)
FOLF-CB
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU
干预措施: Bevacizumab (Drug)
FOLF-CB
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU
干预措施: Leucovorin (Drug)
FOLF-CB
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU
干预措施: Fluorouracil (Drug)
FOLF-CB
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU
干预措施: Cetuximab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 12 months
From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring). Kaplan-Meier median PFS time and PFS rate (at 12 months)
Progression-free Survival (PFS) Rate at 1 Year.
时间窗: 12 months
From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).
次要结局
- Objective Response Rate(12 months)
- Overall Survival (OS)(up to 4 years)