A Randomized, Placebo-Controlled Phase II Clinical Trial of Combination Erlotinib (Tarceva) and Celecoxib (Celebrex) Versus Erlotinib (Tarceva)/Placebo in Advanced Non-Small Cell Lung Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Erlotinib hydrochloride and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with celecoxib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving erlotinib hydrochloride together with celecoxib works compared with erlotinib hydrochloride alone in treating patients with stage IIIB-IV non-small cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. Comparison of progression-free survival (PFS) in patients receiving erlotinib + celecoxib vs. erlotinib + placebo for advanced NSCLC.
SECONDARY OBJECTIVES:
I. Objective tumor response rate as defined by RECIST Criteria for subjects receiving erlotinib/celecoxib treatment arms.
II. Categorize the change in e-cadherin expression from baseline to week 8 in a subset of subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
Arm II
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
干预措施: fluorescence in situ hybridization (Genetic)
Arm II
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
干预措施: mutation analysis (Genetic)
Arm I
Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
干预措施: erlotinib hydrochloride (Drug)
Arm I
Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
干预措施: placebo (Other)
Arm I
Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
干预措施: laboratory biomarker analysis (Other)
Arm I
Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
干预措施: immunohistochemistry staining method (Other)
Arm I
Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
干预措施: fluorescence in situ hybridization (Genetic)
Arm I
Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
干预措施: mutation analysis (Genetic)
Arm I
Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
干预措施: protein expression analysis (Genetic)
Arm I
Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
干预措施: gene expression analysis (Genetic)
Arm II
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
干预措施: erlotinib hydrochloride (Drug)
Arm II
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
干预措施: celecoxib (Drug)
Arm II
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
干预措施: laboratory biomarker analysis (Other)
Arm II
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
干预措施: immunohistochemistry staining method (Other)
Arm II
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
干预措施: protein expression analysis (Genetic)
Arm II
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
干预措施: gene expression analysis (Genetic)
结局指标
主要结局
Progression-free Survival
时间窗: Until disease progression, up to 5 years.
Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
次要结局
- Number of Participants With Overall Response(16 weeks post start of treatment)
- Progression-free Survival - Elevated PGEM(Until disease progression, up to 5 years.)
- Progression-free Survival - Low PGEM(Until disease progression, up to 5 years.)
- Progression-free Survival - EGRF(Until disease progression, up to 5 years.)