A Phase II Study Of Capecitabine In Previously Treated, Recurrent And/Or Metastatic Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Rate of Response
研究概览
简要总结
This study plans to examine the effects of Capecitabine administered as an oral chemotherapy drug in participants with nasopharyngeal cancer.
Capecitabine is an oral prodrug. A "prodrug" is a drug that is converted within the body into its active form that has medical effects. Capecitabine is a prodrug of 5-fluorouracil (5-FU), which is a chemotherapy agent frequently used to treat head and neck cancers. Capecitabine is absorbed through the gastrointestinal tract and is converted to 5-FU. Capecitabine (Xeloda9) has been tested in subjects with colorectal and breast cancers, and shown to be effective in those cancers. Likewise, 5-FU has shown benefit when administered as a continuous infusion for those with nasopharyngeal cancers. Since Capecitabine is a prodrug of 5-FU, it is possible that similar results will be achieved.
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have locally recurrent or metastatic nasopharyngeal cancer.
详细描述
This is a nonrandomized, multicenter study.
- Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days.
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
Capecitabine
Capecitabine (Xeloda 4:14. ) 150 mg and 500 mg tablets. Capecitabine will be administered at a dose of 1000 mg/m2 twice daily, for a total daily dose of 2000 mg/m 2. Capecitabine will administered P.O. or per G-tube B.I.D. for 14 days, followed by a one-week rest period in 3-week cycles.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Rate of Response
时间窗: 4 weeks
Tumor response rate based on tumor measurement (according to the nasT criteria). Response Evaluation Criteria in Solid Tumors (RECIST).
次要结局
- Correlation of Epstein-Barr virus (EBV) with response as assessed by a two-sample t-test with arcsin approximation(Baseline and every 2 cycles)
- Correlation of EBV status to thymidine phosphorylase expression as assessed by Fischer's exact test(Basleine and every 2 cycles)
- Correlation of response to thymidine phosphorylase expression as assessed by Fischer's exact test(Baseline and every 2 cycles)
- Rate of Progression Free Survival(Study Day 1 to the date of first known disease progression, or the date of death if the patient)
- Rate of Overall Survival(Study Day 1 to the date of death or the last date patient was known to be alive)
研究者
Lori J. Wirth, MD
Wirth, Lori MD
Dana-Farber Cancer Institute