Phase II Clinical, Biological and Pharmacological Study of Rapamycin (Rapamune®, Sirolimus) in Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Response Rate (Complete, Partial Response and Stable Disease) as Assessed by RECIST
研究概览
简要总结
RATIONALE: Sirolimus 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 sirolimus works in treating patients with advanced pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- To determine the proportion of patients with previously treated advanced pancreatic cancer surviving at 6 months after treatment with single agent rapamycin.
- To evaluate the relationship between activation of the PI3/Akt/mTOR/S6K signaling pathway in tumor tissues and rapamycin activity in this patient population.
- To characterize toxicity of rapamycin in this patient population.
Secondary
- To determine the response rate, median time to treatment failure, and median survival of patients with previously treated advanced pancreatic cancer who are treated with single agent rapamycin.
- To characterize the pharmacokinetics of rapamycin in this patient population.
- To explore pharmacogenomic variables that affect rapamycin pharmacokinetics and clinical activity in this patient population.
- To determine the pharmacodynamic effects of rapamycin on S6 kinase activation in PBMC, normal skin, and normal oral mucosa obtained from patients treated with the drug and its relationship with rapamycin pharmacokinetics and clinical effects.
- To explore biomarkers in tumor tissues that might be associated with rapamycin clinical effects.
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 120 Years（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
Sirolimus
Sirolimus 5mg. po QD continously (28 days=cycle)
干预措施: sirolimus (Drug)
结局指标
主要结局
Response Rate (Complete, Partial Response and Stable Disease) as Assessed by RECIST
时间窗: response at 2 and 6 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Response for Stable disease was assessed at 2 months and for complete and partial response at 6 months.
Severity of Adverse Events as Assessed by NCI CTCAE v3.0
时间窗: 6 months
Percentage of Patients With Overall Survival at 6 Months
时间窗: 6- month survival rate (6mSR)
次要结局
未报告次要终点