NCT00436241已完成2 期
A Open Label Study of the Effect of First-line Therapy With Xeloda in Combination With Oxaliplatin on Overall Response Rate in Patients With Locally Advanced and/or Metastatic Gastric 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
- 45
- 主要终点
- Overall response rate
研究概览
简要总结
This single arm study will assess the efficacy and safety of Xeloda in combination with oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric cancer who have had no prior chemotherapy for advanced or metastatic disease. Eligible patients will receive Xeloda 1000mg/m2 po twice daily, D1-D10 every 2 weeks (10 days treatment followed by 4 days rest period) plus oxaliplatin 85 mg/m2/day iv, D1 every 2 weeks. The anticipated time on study treatment is until disease progression, 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;
- •gastric cancer with unresectable locally advanced and/or metastatic disease;
- •>=1 measurable lesion;
- •ambulatory, with ECOG Performance Status >=1.
排除标准
- •previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to enrollment);
- •clinically significant cardiac disease or myocardial infarction within last 12 months;
- •CNS metastases;
- •history of other malignancy within last 5 years, except for cured basal cell cancer of the skin, or in situ cancer of the cervix.
研究组 & 干预措施
1
Experimental
干预措施: Oxaliplatin (Drug)
1
Experimental
干预措施: capecitabine [Xeloda] (Drug)
结局指标
主要结局
Overall response rate
时间窗: Event driven
次要结局
- Time to disease progression, overall survival, duration of response, time to response.(Event driven)
- AEs, laboratory parameters.(Throughout study)
研究者
相似试验
已完成
2 期
A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.Nasopharyngeal CancerNCT00439426Hoffmann-La Roche25
已完成
2 期
A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal CancerColorectal CancerNCT00796718Hoffmann-La Roche62
已完成
1 期
A Study of Xeloda (Capecitabine) in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer.Colorectal CancerNCT00353262Hoffmann-La Roche36
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 Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.Colorectal CancerNCT01135498Hoffmann-La Roche90