A Randomized, Open-label Study of the Effect of 2 Different Treatment Schedules of Xeloda With Eloxatin and Avastin on Progression-free Survival in Treatment-naïve Patients With Locally Advanced or Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 435
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.
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
- •Metastatic or inoperable locally advanced colorectal cancer
- •>=1 measurable target lesion
排除标准
- •Previous systemic therapy for advanced or metastatic disease
- •Previous treatment with bevacizumab
研究组 & 干预措施
1
干预措施: capecitabine (Drug)
1
干预措施: Oxaliplatin (Drug)
1
干预措施: bevacizumab (Drug)
2
干预措施: capecitabine (Drug)
2
干预措施: Oxaliplatin (Drug)
2
干预措施: bevacizumab (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Time to disease progression or death (through follow-up phase)
Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).
次要结局
- Overall Survival(Time to death (through follow-up phase): Approximate Median of 718 days)
- Best Overall Clinical Response(Through follow-up phase: Approximate Median of 318 days)
- Duration of Overall Clinical Response (CR or PR)(Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days)