Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 6
- 主要终点
- Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
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 rebeccamycin analogue in treating patients who have advanced liver and/or biliary cancer.
详细描述
OBJECTIVES:
- Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
- Assess the toxicity associated with this drug in this patient population.
- Evaluate the survival of this patient population treated with this drug.
- Determine the pharmacokinetics of this drug in this patient population.
OUTLINE: This is a partial dose-escalation study.
Patients receive rebeccamycin analogue IV over 1 hour daily on days 1-5. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are assigned to 1 of 2 cohorts according to hepatic dysfunction. (Cohort I closed to accrual as of 11/1/03.)
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
结局指标
主要结局
Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
时间窗: Patients are followed every 3 months.
次要结局
- Assess the toxicity associated with this drug in this patient population.(Patients are followed every 3 months.)