A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,814
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of colon or rectal cancer
- •No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received >12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received >6 months prior to study entry.
排除标准
- •Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib.
- •Poorly controlled hypertension
研究组 & 干预措施
2
Cediranib + FOLFOX
干预措施: Oxaliplatin (in FOLFOX) (Drug)
1
Bevacizumab + FOLFOX
干预措施: Bevacizumab (Drug)
1
Bevacizumab + FOLFOX
干预措施: 5-fluorouracil ( in FOLFOX) (Drug)
1
Bevacizumab + FOLFOX
干预措施: Leucovorin (in FOLFOX) (Drug)
1
Bevacizumab + FOLFOX
干预措施: Oxaliplatin (in FOLFOX) (Drug)
2
Cediranib + FOLFOX
干预措施: Cediranib (Drug)
2
Cediranib + FOLFOX
干预措施: 5-fluorouracil ( in FOLFOX) (Drug)
2
Cediranib + FOLFOX
干预措施: Leucovorin (in FOLFOX) (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression
Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
次要结局
- Overall Survival(Randomisation until data cut-off)
- Objective Response Rate(Up until data cut-off)
- Duration of Response(Up until data cut-off date of 15/11/2007)
- Percentage Change in Tumour Size(Baseline to Week 8)
- Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)(Baseline through to data cut-off)