NCT01110785Unknown2 期
Safety and Efficacy of the Addition of Simvastatin to Panitumumab in K-ras Mutant Advanced or Metastatic Colorectal Cancer Patients. A Single-Arm, Multicenter, Phase II Study Using a Simon Two Stage Design.
Leiden University Medical Center8 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2010年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 46
- 试验地点
- 8
- 主要终点
- Percentage of patients free from progression and alive at 11 weeks after the first dose of panitumumab measured by RECIST v 1.1
研究概览
简要总结
RATIONALE: Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, 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 simvastatin together with panitumumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well simvastatin given together with panitumumab works in treating patients with advanced or metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- To determine if the proportion (at least 40%) of patients with K-ras mutant-type advanced or metastatic colorectal cancer are free from progression and alive based on RECIST criteria version 1.1 at 11 weeks after the first administration of panitumumab (i.e., 12.5 weeks after the scan at baseline at start of simvastatin).
- To determine if these results are comparable with historical results of k-ras wild-type colorectal carcinoma patients treated with panitumumab.
- To evaluate clinical signs of progression (according to RECIST criteria) in patients treated with this regimen.
Secondary
- To evaluate the safety of this regimen in these patients who have failed prior treatment with fluorouracil-, oxaliplatin-, and irinotecan-containing regimens.
- To evaluate the overall survival of patients who are treated with this regimen and have failed prior fluorouracil-, oxaliplatin-, and irinotecan-containing regimens.
- To evaluate the progression-free survival (based on RECIST criteria version 1.1) of these patients.
- To evaluate the objective response rate (based on RECIST criteria version 1.1) in these patients.
- To evaluate the correlation between skin toxicity and anti-tumor response in these patients.
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 colorectal cancer
- •Advanced or metastatic disease
- •Failed prior fluorouracil-, oxaliplatin- and irinotecan-containing regimens
- •In case of progressive disease within 6 months after start of adjuvant fluorouracil-, oxaliplatin-, and irinotecan-containing regimens, the adjuvant therapy is considered to be treatment for metastatic disease
- •Mutant-type k-ras status (mutation in codon 12, 13, or 61) on tumor material
- •Measurable disease according to RECIST criteria version 1.1
- •Progressive disease in the past 3 months according to RECIST criteria version 1.1
- •No symptomatic brain metastases, defined as any symptoms during the past 6 months
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •WBC ≥ 2.0 x 10^9/L
- •ANC ≥ 1.5 x 10^9/L
- •Platelet count ≥ 100 x 10^9/L
- •Hemoglobin ≥ 9 g/dL
- •Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST/ALT ≤ 3 times ULN (≤ 5 times ULN in case of liver metastases)
- •Creatinine clearance ≥ 60 mL/min
- •Magnesium normal
- •Calcium normal
- •Creatine phosphokinase ≤ 2.5 times ULN
- •Not pregnant or nursing
- •Not planning to become pregnant within 6 months after the end of study treatment
- •Fertile patients must use highly effective contraception during and for 6 months after completion of study therapy
- •No noncompliance in previous studies
- •No alcohol use > 4 units/day or unwilling to abstain from use
- •No history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or signs of interstitial lung disease on baseline CT scan
- •No clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, or serious uncontrolled cardiac arrhythmia) < 1 year prior to study
- •No symptomatic hypothyroidism
- •No history of toxicity during statin use
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior EGFr-therapy, including monoclonal antibodies (e.g., panitumumab or cetuximab)
- •No concurrent verapamil, amiodarone, or dronedarone or unwilling to abstain from use
排除标准
- 未提供
结局指标
主要结局
Percentage of patients free from progression and alive at 11 weeks after the first dose of panitumumab measured by RECIST v 1.1
次要结局
- Median and mean overall survival
- Median and mean progression-free survival
- Objective response rate
- Correlation between skin toxicity and response to treatment
- Serum cholesterol and subsequent treatment response
- Correlation between PTEN, PIK3CA, b-raf, ERK, and MEK status and objective response rate
- Toxicity measured by NCICTC v 3.0
- Correlation between single nucleotide polymorphisms and objective response rate
- Correlation between proteomics and objective response rate
研究者
研究点 (8)
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