Safety and Efficacy of the Addition of Simvastatin to Cetuximab in K-ras Mutant Advanced or Metastatic Colorectal Cancer Patients. A Single-Arm, Multicenter, Phase II Study Using a Simon Two Stage Design.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Percentage of patients free from progression and alive after 12.5 weeks following the first dose of treatment
研究概览
简要总结
RATIONALE: 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. Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Simvastatin may help cetuximab work better by making tumor cells more sensitive to cetuximab. Giving cetuximab together with simvastatin may kill more tumor cells.
PURPOSE: This phase II trial is studying giving cetuximab together with simvastatin in treating patients with advanced or metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- To determine the percentage of patients with k-ras mutant, advanced or metastatic colorectal cancer who are free from progression and alive after 12.5 weeks following the first dose of cetuximab in combination with simvastatin.
Secondary
- To determine the correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy.
- To determine the predictive value of PTEN, PIK3CA, b-raf, and ERK and MEK status. (exploratory)
- To determine the predictive value of SNPs, proteomics, and circulating DNA. (exploratory)
- To evaluate cholesterol, proteomics, and circulating DNA as biomarkers in this setting. (exploratory)
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of advanced or metastatic colorectal cancer
- •Progressive disease in the past 3 months
- •Failed prior oxaliplatin-, fluorouracil (5-FU)-, and irinotecan-containing regimens AND have the presence of a k-ras mutation within codon 12, 13, or 61
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Adequate organ function
- •No history of toxicity during statin use
- •No other malignancy within the past 5 years
- •No history of severe pulmonary disease
- •No clinically relevant coronary artery disease
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior epidermal growth factor receptor (EGFR)-targeting agents
- •No concurrent verapamil or amiodarone
排除标准
- 未提供
结局指标
主要结局
Percentage of patients free from progression and alive after 12.5 weeks following the first dose of treatment
次要结局
- Correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy