A Randomized, Open Label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Irinotecan + 5-fluorouracil/Folinic Acid, and Irinotecan + 5-fluorouracil/Folinic Acid Alone, on Progression-free Survival in Chinese Patients With Metastatic Colorectal Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 214
- 主要终点
- Progression-free survival.
研究概览
简要总结
This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 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
- •adult patients, >=18 years of age;
- •histologically confirmed adenocarcinoma of the colon or rectum, with metastatic disease;
- •>=1 measurable lesion;
- •ECOG performance status of <=1.
排除标准
- •prior systemic therapy for advanced or metastatic disease;
- •adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
- •other malignancy within past 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
- •clinically significant cardiovascular disease in past 6 months.
研究组 & 干预措施
2
干预措施: leucovorin (Drug)
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: fluorouracil (Drug)
2
干预措施: irinotecan (Drug)
2
干预措施: fluorouracil (Drug)
结局指标
主要结局
Progression-free survival.
时间窗: 6 months
次要结局
- AEs, laboratory tests(Throughout study)
- Overall response rate, time to response, duration of response, overall survival.(Event driven)