A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma
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 study will evaluate the efficacy, safety, tolerability, and effect on quality of life of oral capecitabine in combination with intravenous (IV) cisplatin in participants with metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine treatment, and cisplatin will be administered on the first day of each cycle. The anticipated time on study treatment is up to 24 weeks, and the target sample size is 44 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
- •Adults 18 to 75 years of age
- •Histologically confirmed, poorly differentiated or undifferentiated metastatic nasopharyngeal cancer with at least 1 measurable lesion which has not been irradiated
- •Ability to swallow and retain oral medication
排除标准
- •Previous cytotoxic chemotherapy except adjuvant, concurrent, or neoadjuvant treatment completed at least 6 months before enrollment
- •Clinically significant cardiac disease
- •History of other malignancy within the last 5 years except cured basal cell cancer of the skin or cured cancer in situ of the cervix
- •Radiotherapy within 4 weeks of treatment start or any prior radiotherapy performed to the indicator lesion(s) being measured in the study
研究组 & 干预措施
Capecitabine + Cisplatin
Participants with metastatic nasopharyngeal cancer will receive combination treatment with capecitabine (1000 milligrams per meter square [mg/m^2] tablets twice daily [BID] orally) and cisplatin (100 mg/m^2/day intravenous [IV] infusion) for up to 8 cycles.
干预措施: Capecitabine (Drug)
Capecitabine + Cisplatin
Participants with metastatic nasopharyngeal cancer will receive combination treatment with capecitabine (1000 milligrams per meter square [mg/m^2] tablets twice daily [BID] orally) and cisplatin (100 mg/m^2/day intravenous [IV] infusion) for up to 8 cycles.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Overall response rate
时间窗: up to 28 days after the last intake of study treatment (up to approximately 5 years)
次要结局
- Time to disease progression(Up to approximately 18 months)
- Complete response rate(Up to approximately 18 months)
- Overall survival(Up to approximately 18 months)
- Incidence of adverse events(Up to approximately 7 months)
- Duration of response(Up to approximately 18 months)
- Quality of life according to Visual Analog Scale (VAS) score(Up to approximately 6 months)
- Treatment convenience/satisfaction according to VAS score(Up to approximately 6 months)