NCT00048139已完成2 期
An Open-label Study of the Effect of Intermittent Xeloda in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Tumor measurement (RECIST criteria)
研究概览
简要总结
This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •adult patients >=18 years of age;
- •locally advanced and/or metastatic colorectal cancer;
- •>=1 target lesion.
排除标准
- •previous treatment with Xeloda or irinotecan;
- •previous systemic therapy for metastatic disease;
- •progressive disease during previous adjuvant therapy or within 6 months of completion.
研究组 & 干预措施
1
Experimental
干预措施: Irinotecan (Drug)
1
Experimental
干预措施: capecitabine [Xeloda] (Drug)
结局指标
主要结局
Tumor measurement (RECIST criteria)
时间窗: Event driven
次要结局
- Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival.(Event driven)
研究者
相似试验
已完成
2 期
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal CancerColorectal CancerNCT00048126Hoffmann-La Roche57
已完成
3 期
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon CancerColorectal CancerNCT00069121Hoffmann-La Roche1,886
已完成
2 期
A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal CancerColorectal CancerNCT00118755Hoffmann-La Roche435
已完成
3 期
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal CancerColorectal CancerNCT00069108Hoffmann-La Roche627
已完成
1 期
A Study of Xeloda (Capecitabine) in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer.Colorectal CancerNCT00353262Hoffmann-La Roche36