Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment
研究概览
简要总结
The goal of this clinical research study is to find out how effective oxaliplatin and capecitabine are against advanced cancer of the salivary gland. The safety of this treatment as well as how long the cancer responds or stays in a stable state due to the treatment will also be studied.
详细描述
This is a study of two investigational agents called oxaliplatin and capecitabine.
Investigational agents have not received Food and Drug Administration (FDA) approval for the way they are being used in this study. This means an investigation drug is still under study to determine what a safe dose is, what the side effects are and whether or not it is effective in the disease or condition being studied.
Oxaliplatin and capecitabine are chemotherapy agents that have been approved by the FDA for use in other cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
XELOX
- Oxaliplatin 130 mg/m2 day 1 every 3 weeks
- Capecitabine 1700 mg/m2/day days 1-14 every 3 weeks. -- Patients will be evaluated for response at the end of cycle 2 and at the end of every even cycle thereafter.
干预措施: Capecitabine (Drug)
XELOX
- Oxaliplatin 130 mg/m2 day 1 every 3 weeks
- Capecitabine 1700 mg/m2/day days 1-14 every 3 weeks. -- Patients will be evaluated for response at the end of cycle 2 and at the end of every even cycle thereafter.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment
时间窗: Every 2 Cycles
次要结局
- Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment(Every 2 Cycles)
- Toxicity as assessed by CTCAE weekly(Weekly)
- Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3(Baseline andDay 3)