Phase I/II Study of Erlotinib (TARCEVA) and Cetuximab (ERBITUX) in Advanced Solid Tumors, With Emphasis on Non Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of Patients Experiencing a DLT
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving erlotinib together with cetuximab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib and cetuximab and to see how well they work in treating patients with advanced solid tumors or progressive or recurrent stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety and feasibility of erlotinib hydrochloride and cetuximab in patients with advanced solid tumors. (Phase I)
- Determine the efficacy of this regimen, in terms of objective tumor response rate, in patients with advanced non-small cell lung cancer (NSCLC) pre-treated with platinum. (Phase II)
Secondary
- Determine the maximum tolerated dose of this regimen in these patients. (Phase I)
- Determine the efficacy of this regimen, in terms of response rate, in these patients. (Phase I)
- Determine the progression-free and overall survival of patients treated with this regimen. (Phase II)
- Determine the frequency and severity of toxicities of this regimen in these patients. (Phase II)
- Determine epidermal growth factor receptor (EGFR) and K-RAS mutation status. (Phase II)
- Evaluate EGFR protein expression and protein expression of downstream markers (e.g., pMAPK, pAKT, p27, and Ki-67). (Phase II)
- Evaluate the levels of marker proteins (e.g., pMAPK, pAKT, p27, and Ki-67) in buccal cells. (Phase II)
- Determine gene copy number by EGFR fluorescent in situ hybridization (FISH). (Phase II)
- Identify EGFR polymorphisms by analysis of genomic DNA from peripheral blood mononuclear cells. (Phase II)
- Determine if the continued presence or absence of mutant K-RAS tumor DNA correlates with response and/or outcome. (Phase II)
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
- 未提供
研究组 & 干预措施
Erlotinib + Cetuximab
Daily erlotinib combined with weekly cetuximab
干预措施: cetuximab (Drug)
Erlotinib + Cetuximab
Daily erlotinib combined with weekly cetuximab
干预措施: erlotinib (Drug)
结局指标
主要结局
Number of Patients Experiencing a DLT
时间窗: baseline through cycle 1 of treatment
Patients will be followed during cycle 1 for the occurrence of a protocol defined dose limiting toxicity
Number of Patients Correlated With Best Overall Response.
时间窗: Every two cycles from first dose to last dose of study drugs
To determine the efficacy, as measured by objective tumor response rate (RICIST criteria), of daily oral erlotinib and weekly intravenous cetuximab in patients with advanced NSCLC. Best overall response per patient will be reported below.
次要结局
- Patient Outcome(Patients will be followed until death)