NCT00257426已完成2 期
A Phase II Study of Octreotide Acetate for the Treatment of Advanced 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
- 31
- 试验地点
- 1
- 主要终点
- Median survival
研究概览
简要总结
RATIONALE: Octreotide may stop or slow the growth of tumor cells and may be an effective treatment for liver cancer.
PURPOSE: This phase II trial is studying how well octreotide works in treating patients with locally advanced or metastatic liver cancer.
详细描述
OBJECTIVES:
Primary
- To verify that long-acting somatostatin analog octreotide (Sandostatin LAR) depot will extend median survival from 5 months to 8.75 months in patients with locally advanced or metastatic hepatocellular carcinoma with a CLIP score of 3 or more.
Secondary
- To document tolerability of this drug in this patient population.
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
- •DISEASE CHARACTERISTICS:
- •Newly diagnosed or recurrent hepatocellular carcinoma (HCC) as defined by tissue biopsy OR alpha fetoprotein (AFP) > 1,000 ng/mL with compatible mass on CT scan or MRI
- •Recurrence of previously resected HCC will not require tissue confirmation if there is clear radiographic recurrence, in the judgment of the investigator
- •Locally advanced OR metastatic disease
- •Unmeasurable disease allowed if initial diagnosis was made according to the above criteria and/or recurrence has been confirmed by tissue biopsy or radiological imaging
- •CLIP score ≥ 3
- •Not a candidate for surgical resection or liver transplant
- •Not a candidate for loco-regional therapy (e.g., ablation, embolization, hepatic arterial infusion therapy), but could have received such therapy in the past
- •No fibrolamellar HCC
- •No clinically apparent central nervous system metastases or carcinomatous meningitis
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 8 weeks
- •Karnofsky performance status 60-100%
- •Hemoglobin ≥ 8.5 g/dL
- •Platelet count ≥ 50,000/mm³
- •Total bilirubin ≤ 5.0 mg/dL
- •AST or ALT ≤ 5 times upper limit of normal (ULN)
- •Creatinine ≤ 2 times ULN
- •INR ≤ 2.5
- •No active variceal bleeding within the past 3 months
- •No encephalopathy grade 3-4
- •No ongoing ethanol or intravenous drug abuse
- •Not pregnant or breast feeding
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Any number of prior therapies (e.g., chemotherapy, resection, embolization, or radiofrequency/ethanol ablation therapy) allowed
- •No concurrent chemotherapy, radiotherapy, or immunotherapy
排除标准
- 未提供
结局指标
主要结局
Median survival
时间窗: 6 months
次要结局
- number of subjects with toxicities(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent ThymomaThymoma and Thymic CarcinomaNCT00003283Eastern Cooperative Oncology Group38
已完成
1 期
Octreotide and Doxorubicin in Treating Patients With Advanced CancerUnspecified Adult Solid Tumor, Protocol SpecificNCT00008073University of Pittsburgh
已完成
2 期
AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine TumorsIslet Cell TumorNeoplastic SyndromeGastrointestinal Carcinoid TumorNCT00427349Eastern Cooperative Oncology Group46
撤回
2 期
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine TumorsGastrointestinal Carcinoid TumorIslet Cell CarcinomaNCT00227773Eastern Cooperative Oncology Group
已完成
2 期
Thalidomide and Epoetin Alfa in Treating Anemia in Patients With Myelodysplastic SyndromeMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsLeukemiaAnemiaNCT00053001Fallon Clinic