A Phase II Study of ZD1839 (Iressa, Gefitinib, NSC 715055) in Advanced Unresectable Hepatocellular Carcinoma
概览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Progression-free survival rate in patients treated with ZD 1839
概览
简要总结
Phase II trial to study the effectiveness of gefitinib in treating patients who have advanced unresectable hepatocellular carcinoma (liver cancer). Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the ability of ZD1839 to improve progression free survival in patients with advanced unresectable hepatocellular carcinoma.
II. Evaluate response rate of ZD1839 in advanced unresectable hepatocellular carcinoma.
III. Evaluate the effect of ZD1839 on measurable disease in patients with unresectable hepatocellular carcinoma.
IV. Evaluate the effect of ZD1839 on serum alpha-fetoprotein levels in patients with abnormal pretreatment serum levels.
V. Evaluate toxicity of ZD1839 in advanced unresectable hepatocellular carcinoma.
VI. Investigate biologic markers for outcome in patients with unresectable hepatocellular carcinoma treated with ZD1839.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 years from study entry.
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
- 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
- •Patients must have advanced unresectable hepatocellular carcinoma based on the following criteria:
- •Histologically or cytologically confirmed, OR
- •Alpha-fetoprotein \> 400 ng if patient is not hepatitis surface antigen positive, OR
- •Alpha-fetoprotein \> 4000 ng if patient is hepatitis surface antigen positive
- •NOTE: If available, tissue should be submitted to assess EGFR/pathway expression
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan, assessed within 4 weeks prior to randomization/registration
- •Prior use of liver-directed therapy (radio-frequency ablation, cryoablation, percutaneous ethanol injection, chemo-embolization, hepatic artery embolization and hepatic artery infused FUDR) is allowed, provided the patient has either progressive hepatic disease or measurable extrahepatic disease
- •ECOG performance status of 0, 1 or 2
- •Leukocytes \>= 2,000/uL OR
- •Absolute neutrophil count \>= 1,000/uL
排除标准
- 未提供
研究组 & 干预措施
Treatment (gefitinib)
Patients receive oral gefitinib daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: gefitinib (Drug)
Treatment (gefitinib)
Patients receive oral gefitinib daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Progression-free survival rate in patients treated with ZD 1839
时间窗: From the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, assessed up to 4.5 months
A 4.5-month (PFS) rate of 63% or more will be taken as evidence of activity in this patient population.
次要结局
- Grade 3 or higher toxicity(Up to 3 years)
- EGFR expression(Baseline)
- Response (CR+PR) measured by RECIST(Up to 3 years)