NCT00058487已完成2 期
A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Antitumor activity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of hepatocellular (liver) cancer by stopping blood flow to the tumor. Combining epirubicin with thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with thalidomide in treating patients who have unresectable or metastatic liver cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of epirubicin and thalidomide in patients with locally unresectable or metastatic hepatocellular carcinoma.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients receive epirubicin on days 1, 8, and 15 and thalidomide on days 1-21. Courses repeat every 28 days.
PROJECTED ACCRUAL: A total of 12 patients per year will be accrued for this study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of hepatocellular carcinoma
- •Locally unresectable or metastatic disease
- •Measurable disease
- •No clinically apparent CNS metastases
- •No carcinomatous meningitis
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 75,000/mm^3
- •SGOT no greater than 5 times upper limit of normal
- •Bilirubin no greater than 3.0 mg/dL
- •INR no greater than 1.5*
- •Albumin at least 2.0 g/dL NOTE: *Not required for patients receiving full anticoagulation with warfarin for deep vein thrombosis or pulmonary embolism
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular
- •No myocardial infarction within the past 6 months
- •LVEF normal by echocardiogram or MUGA
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Willing and able to participate in the System for Thalidomide Education and Prescribing Safety (STEPS) program
- •No uncontrolled serious medical or psychiatric illness
- •No other concurrent uncontrolled malignancy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No more than 1 prior chemotherapy regimen for hepatocellular carcinoma
- •No prior chemoembolization to the liver
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •More than 2 weeks since prior major surgery
排除标准
- 未提供
结局指标
主要结局
Antitumor activity
Toxic effects
次要结局
未报告次要终点
研究者
研究点 (4)
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