A Phase II Study of AZD2171 in Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
This phase II trial is studying how well AZD2171 works in treating patients with locally advanced unresectable or metastatic liver cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
详细描述
PRIMARY OBJECTIVE:
I. Assess the progression free survival of patients with locally advanced unresectable or metastatic hepatocellular carcinoma treated with AZD2171.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this drug in these patients. II. Determine, preliminarily, the efficacy of this drug, in terms of response rate, duration of response, and overall survival, in these patients.
III. Determine the blood flow changes and vascular permeability of the tumor in patients treated with this drug.
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
- •Histologically or cytologically confirmed hepatocellular carcinoma
- •Locally advanced unresectable OR metastatic disease
- •Cancer of the Liver Italian Program (CLIP) score =< 3
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Measurable disease, defined as >= 1 unidimensionally measurable lesion>= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- •Cardiac arrhythmia
- •Measurable lesion must be outside field of prior chemoembolization
- •No known brain metastases
- •ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •Life expectancy > 12 weeks
- •Absolute neutrophil count >= 1,000/mm^3
- •Platelet count >= 75,000/mm^3
- •Hemoglobin >= 8 g/dL
- •Bilirubin =< 3.0 mg/dL
- •AST and ALT =< 7 times upper limit of normal
- •Creatinine =< 2.0 mg/dL
- •Fertile patients must use effective contraception
- •CLIP score =< 3
排除标准
- •Not pregnant or nursing
- •Negative pregnancy test
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD2171
- •No chronic diarrhea or any disorder that would limit adequate absorption of AZD2171
- •No familial history of long QT syndrome
- •Proteinuria =< +1 on two consecutive dipsticks taken no less than 1 week apart
- •No other uncontrolled illness including, but not limited to, any of the following:
- •Hypertension
- •Ongoing or active infection
- •No psychiatric illness or social situation that would limit study compliance
- •Recovered from prior therapy
- •Prior systemic chemotherapy regimens for hepatocellular carcinoma allowed
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- •More than 4 weeks since prior radiotherapy, major surgery, or chemoembolization
- •At least 30 days since prior participation in an investigational trial
- •No other concurrent investigational agents
- •No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, or pentamidine)
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent anticancer agents or therapies
- •No mean QTc > 470 msec (with Bazett's correction) on screening EKG (490 msec for women)
研究组 & 干预措施
AZD2171
Patients will receive AZD2171 (cediranib maleate) 30mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
干预措施: cediranib maleate (Drug)
AZD2171
Patients will receive AZD2171 (cediranib maleate) 30mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
干预措施: laboratory biomarker analysis (Other)
AZD2171
Patients will receive AZD2171 (cediranib maleate) 30mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
干预措施: computed tomography (Procedure)
AZD2171
Patients will receive AZD2171 (cediranib maleate) 30mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
干预措施: dynamic contrast-enhanced magnetic resonance imaging (Procedure)
AZD2171
Patients will receive AZD2171 (cediranib maleate) 30mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
干预措施: pharmacological study (Other)
结局指标
主要结局
Progression-free Survival
时间窗: 3 months
Progression is defined as a 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions by conventional RECIST based criteria, or death, which ever comes first. This design yields at least 90% power to detect a true 3-month PFS rate of at least 69%.
次要结局
- Response Rate(Up to 1 year)
- Overall Survival(The time from study entry until death from any cause, assessed up to 1 year)