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
- 3
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of advanced hepatobiliary carcinoma not amenable to conventional surgery
- •Gall bladder carcinoma
- •Cholangiocarcinoma
- •Carcinoma of the ampulla
- •Hepatocellular carcinoma (eligible for cohort II only)
- •Measurable disease
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin greater than 10 g/dL
- •Bilirubin less than 3 mg/dL
- •Cohort I (closed to accrual as of 11/1/03)
- •Bilirubin no greater than 1.5 mg/dL
- •AST no greater than 2.5 times upper limit of normal (ULN)
- •Cohort II
- •Bilirubin greater than 1.5 mg/dL and less than 3 mg/dL OR
- •Bilirubin no greater 1.5 mg/dL AND AST greater than 2.5 times ULN
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy for cholangiocarcinoma or hepatobiliary carcinoma
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •No concurrent combination antiviral therapy for HIV-positive patients
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.)