A Phase I Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Capecitabine in Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Maximum tolerated doses of vorinostat (SAHA) and capecitabine
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as vorinostat and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and capecitabine in treating patients with unresectable or metastatic solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of vorinostat (SAHA) and capecitabine in patients with metastatic or unresectable solid tumors.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Correlate the clinical effects with the pharmacokinetic effects of this regimen in these patients.
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
SAHA (Suberoylanilide Acid) with Capecitabine
干预措施: capecitabine (Drug)
SAHA (Suberoylanilide Acid) with Capecitabine
干预措施: vorinostat (Drug)
结局指标
主要结局
Maximum tolerated doses of vorinostat (SAHA) and capecitabine
时间窗: 1 cycle
Safety and tolerability as assessed by CTCAE v3.0
时间窗: All cycles
次要结局
- Response rate as assessed by RECIST criteria(Every 2 cycles)
- Molecular markers as assessed by molecular analysis(Cycle 1)
- Survival(progression free survival every 2 cycles)