NCT00095992已完成2 期
A Phase II Study Of SB-715992 (NSC 727990) In Patients With Locally Advanced, Recurrent 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
- 15
- 试验地点
- 8
- 主要终点
- Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with locally advanced, recurrent, or metastatic liver cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of SB-715992, in terms of response rate and stable disease rate, in patients with locally advanced, recurrent, or metastatic hepatocellular carcinoma.
- Determine the toxicity of this drug in these patients.
- Determine the early progression rate and response duration in patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Correlate pharmacokinetics with safety and efficacy of this drug in these patients.
- Correlate tumor expression of β-tubulin and kinesin spindle protein with clinical outcomes in patients treated with this drug.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
All patients are followed at 4 weeks. Patients with ongoing stable or responding disease are followed every 3 months until relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed hepatocellular carcinoma
- •Locally advanced, recurrent, or metastatic disease
- •Histologically confirmed disease must have archival paraffin-fixed tumor specimen available
- •Measurable disease
- •At least 1 unidimensionally measurable site of disease ≥ 20 mm by x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm by spiral CT scan
- •Outside of previously irradiated area
- •Patients whose sole site of disease is in a previously irradiated field are eligible provided there is evidence of disease progression OR new lesions documented in the irradiated field
- •Bone metastases are not considered measurable disease
- •Not curable by standard therapies
- •No cholangiocarcinoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 80,000/mm^3
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •AST ≤ 5 times ULN
- •Must have hepatic reserve of Child-Turcotte-Pugh class A or better
- •Creatinine clearance ≥ 60 mL/min
- •Cardiovascular
- •No myocardial infarction within the past 6 months
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No active cardiomyopathy
- •No uncontrolled hypertension
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No clinical evidence of encephalopathy
- •No ongoing or active infection
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 4 weeks since prior intra-hepatic chemotherapy as a component of trans-arterial chemoembolization and recovered
- •Documented disease progression
- •No prior systemic chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- 另有 34 项未显示
排除标准
- 未提供
结局指标
主要结局
Response
时间窗: 4 years
次要结局
- Molecular correlates on archival tumor specimens and peripheral blood mononuclear cells (PBMCs)(4 years)
- Toxicity(4 years)
- Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is adjusted)(4 years)
研究者
研究点 (8)
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