NCT00439426已完成2 期
An Open Label Study of First Line Chemotherapy With Xeloda in Combination With Cisplatin on Treatment Response in Patients With Metastatic Nasopharyngeal 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
- 25
- 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 + oxaliplatin when given as first line treatment for patients with metastatic nasopharyngeal cancer. Patients will receive Xeloda (1000mg/m2 bid orally from day 1 to day 14, followed by a rest period of 7 days) plus oxaliplatin (130mg/m2 iv infusion on day 1 of each 21 day cycle) for 6-8 cycles. 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •history of nasopharyngeal cancer and distant metastases;
- •no previous chemotherapy in past 6 months;
- •recovery from previous radiotherapy;
- •ability to swallow and retain oral medication.
排除标准
- •previous cytotoxic chemotherapy;
- •radiotherapy within 4 weeks of treatment start;
- •history of another malignancy within the last 5 years;
- •clinically significant cardiac disease.
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
- AEs, laboratory parameters.(Throughout study)
- Time to disease progression or death, survival time, duration of response, complete response rate.(Event driven)
研究者
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