A Phase II Study of the mTOR Inhibitor RAD001 in Previously Treated Patients With Unresectable or Metastatic Adenocarcinoma of the Esophagus and Stomach
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 18
- 主要终点
- Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.
研究概览
简要总结
RATIONALE: Everolimus 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.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with previously treated unresectable or metastatic esophageal cancer or stomach cancer.
详细描述
OBJECTIVES:
Primary
- To determine the overall disease-control rate (complete response, partial response, or stable disease) in patients with previously treated unresectable or metastatic adenocarcinoma of the upper gastrointestinal tract treated with everolimus.
Secondary
- To determine the safety and toxicity of everolimus in these patients.
- To determine the efficacy of everolimus, in terms of time to response, duration of response, time to tumor progression, progression-free survival, and overall survival, in these patients.
- To explore potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in blood and tumor biopsy samples from these patients.
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
- 未提供
排除标准
- •uncontrolled diabetes mellitus, defined as fasting serum glucose > 1.5 times ULN
- •severely impaired lung function
- •known HV infection
- •active, bleeding diathesis
- •unstable angina pectoris, symptomatic congestive heart failure, or myocardial infarction within the past 6 months
- •serious uncontrolled cardiac arrhythmia
- •active or uncontrolled infection requiring parenteral antimicrobials
- •known liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent hepatitis)
- •inability to swallow, impaired gastrointestinal (GI) function, or GI disease (e.g., ulcerative colitis, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) that would significantly alter the absorption of study drugs or preclude the use of oral medications
- •other malignancy within the past 5 years except for nonmelanoma skin cancer or cervical carcinoma in situ
- •known hypersensitivity to everolimus, sirolimus, or temsirolimus or to their excipients
- •other medical conditions that, in the opinion of the investigator, would preclude study participation
- •prior mTOR inhibitors (e.g., rapamycin, CCI-779)
- •concurrent chronic treatment with steroids or another immunosuppressive agent
- •concurrent prophylactic use of hematopoietic growth factors
- •concurrent anticancer agents or therapy (including radiotherapy)
- •other concurrent experimental agents
- •concurrent strong inhibitors or inducers of the isoenzyme CYP3A4
研究组 & 干预措施
Everolimus
Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
干预措施: everolimus (Drug)
Everolimus
Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.
时间窗: Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.
Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
次要结局
- Overall Survival(2.5 year)
- Efficacy in Terms of Progression Free Response(evry 3 months in year 1, every 6 months after that)
- Observed Biomarkers(30 months)
- Biomarker Correlations: Progression Free Survival(30 months)
- Biomarker Correlations: Time to Progression(30 months)