Phase II Trial of Pyrazoloacridine (PZA) in Previously Untreated Hepatocellular Carcinoma (HCC) Patients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Patient Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients who have unresectable primary or metastatic kidney cancer that has not been previously treated.
详细描述
OBJECTIVES: I. Determine the response rate, duration, and survival in previously untreated patients with hepatocellular carcinoma treated with pyrazoloacridine (PZA). II. Determine the nature, degree, and duration of toxic effects of PZA in these patients.
OUTLINE: Patients receive pyrazoloacridine IV over 3 hours every 3 weeks. The minimum treatment period is 2 courses with tumor restaging at 6 weeks. Patients with complete remission (CR) or partial remission (PR) may continue on treatment until refractory (PR) or for at least 3 additional courses (CR). Patients with stable disease continue on therapy for at least 2 more courses. Patients are followed until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 24 months.
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
- 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
Pyrazoloacridine
干预措施: Pyrazoloacridine (Drug)
结局指标
主要结局
Patient Response
时间窗: 6 weeks
次要结局
未报告次要终点