NCT01079767终止2 期
Advanced Hepatocellular Carcinoma on Child B Cirrhosis: Tolerance and Efficacy of Torisel® (Temsirolimus)
Federation Francophone de Cancerologie Digestive1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- 3-month disease-control rate according to RECIST criteria
研究概览
简要总结
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients with advanced liver cancer and cirrhosis.
详细描述
OBJECTIVES:
Primary
- To determine the 3-month disease-control rate according to RECIST criteria in patients with advanced hepatocellular carcinoma and Child-Pugh class B cirrhosis.
Secondary
- To determine the 3-month objective response rate according to RECIST criteria in these patients.
- To determine the 1-month metabolic response rate on PET/CT scan in these patients.
- To determine the 1-month perfusion response rate on hepatic perfusion CT scan in these patients.
- To determine the time to progression in patients treated with this drug.
- To determine the progression-free survival of patients treated with this drug.
- To determine the overall survival of patients treated with this drug.
- To assess quality of life according to QLQ-C30 and QLQ-HCC18 questionnaires.
- To determine the clinical and biological tolerance of this drug in these patients.
- To determine the rate of m-TOR pathway activation and VEGF level.
- To evaluate the pharmacokinetics of this drug in select patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Temsirolimus
Other
Temsirolimus
干预措施: temsirolimus (Drug)
结局指标
主要结局
3-month disease-control rate according to RECIST criteria
时间窗: 2010
次要结局
- 3-month objective response rate according to RECIST criteria(2010)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Temsirolimus and Bevacizumab in Hormone-Resistant Metastatic Prostate Cancer That Did Not Respond to ChemotherapyProstate CancerNCT01083368Case Comprehensive Cancer Center22
已完成
1 期
Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid TumorsExtensive Stage Small Cell Lung CancerHereditary ParagangliomaMalignant ParagangliomaMetastatic Gastrointestinal Carcinoid TumorMetastatic PheochromocytomaRecurrent Breast CancerRecurrent Cervical CancerRecurrent Endometrial CarcinomaRecurrent Gastrointestinal Carcinoid TumorRecurrent Islet Cell CarcinomaRecurrent Neuroendocrine Carcinoma of the SkinRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent PheochromocytomaRecurrent Prostate CancerRecurrent Renal Cell CancerRecurrent Small Cell Lung CancerRecurrent Uterine SarcomaRegional Gastrointestinal Carcinoid TumorRegional PheochromocytomaStage III Cervical CancerStage III Endometrial CarcinomaStage III Neuroendocrine Carcinoma of the SkinStage III Ovarian Epithelial CancerStage III Ovarian Germ Cell TumorStage III Prostate CancerStage III Renal Cell CancerStage III Uterine SarcomaStage IIIA Breast CancerStage IIIA Non-small Cell Lung CancerStage IIIB Breast CancerStage IIIB Non-small Cell Lung CancerStage IIIC Breast CancerStage IV Breast CancerStage IV Endometrial CarcinomaStage IV Neuroendocrine Carcinoma of the SkinStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorStage IV Prostate CancerStage IV Renal Cell CancerStage IV Uterine SarcomaStage IVA Cervical CancerStage IVB Cervical CancerThyroid Gland Medullary CarcinomaMale Breast CancerPancreatic Polypeptide TumorNCT01155258University of Southern California19
已完成
1 期
A Feasibility, Dose-Escalation Study Using Intracerebral Microdialysis to Assess the Neuropharmacodynamics of Temsirolimus in Patients With Primary or Metastatic Brain TumorsBrain and Central Nervous System TumorsMetastatic CancerNCT00784914City of Hope Medical Center12
已完成
2 期
Sirolimus in Treating Patients With Advanced Pancreatic CancerPancreatic CancerNCT00499486Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins47
终止
1 期
Temsirolimus and Valproic Acid in Treating Young Patients With Relapsed Neuroblastoma, Bone Sarcoma, or Soft Tissue SarcomaBrain and Central Nervous System TumorsUnspecified Childhood Solid Tumor, Protocol SpecificSarcomaNeuroblastomaNCT01204450UNC Lineberger Comprehensive Cancer Center7