A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients with metastatic liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
- Determine the efficacy of arsenic trioxide in patients with unresectable metastatic hepatocellular carcinoma.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: Patients receive a loading dose of arsenic trioxide IV over 1-2 hours once daily on days 1-5* in week 1 and then twice weekly in weeks 2-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
NOTE: *The 5-day loading dose is only administered during course 1.
After completion of study treatment, patients are followed at 30 days and then periodically for up to 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed hepatocellular carcinoma
- •Unresectable metastatic disease
- •Ascites allowed provided it is minimal
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC > 2,500/mm^3
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 75,000/mm^3
- •Bilirubin < 2.5 mg/dL
- •AST < 2.5 times upper limit of normal
- •Not specified
- •Cardiovascular
- •QTc interval ≤ 460 msec AND potassium and magnesium normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile female patients must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for ≥ 4 weeks after completion of study treatment for male patients)
- •No blood, ova, or sperm donation during study treatment
- •Potassium > 4.0 mEq/dL
- •Magnesium > 1.8 mg/dL
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent biologic therapy
- •Chemotherapy
- •More than 4 weeks since prior and no other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 4 weeks since prior and no concurrent radiotherapy
- •Not specified
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Safety and tolerability
Efficacy
次要结局
未报告次要终点