A Phase 2 Study of Capecitabine in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
Phase 2 evaluation of capecitabine in patients with advanced or recurrent squamous cell carcinoma of the skin.
详细描述
Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
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 1000 mg/m²
Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m² doses on days 1 to 14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 9 weeks (3 cycles)
Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
次要结局
- Overall Survival (OS) at 1 Year(1 year)
- Progression-free Survival (PFS) at 1 Year(1 year)
- Progression-free Survival (PFS) at 2 Years(2 years)
- Overall Survival (OS) at 2 Years(2 years)
研究者
A. Dimitrios Colevas
Associate Professor of Medicine
Stanford University