EUCTR2014-004299-41-IT进行中（未招募）1 期
ERbitux MEtastatic colorectal cancer Strategy Study: A phase III randomized two arm study with FOLFIRI + Cetuximab until disease progression compared to FOLFIRI + Cetuximab for 8 cycles followed by Cetuximab alone until disease progression in first line treatment of patients with RAS and BRAF wild type metastatic colorectal cancer.
Dipartimento di Scienze Mediche Oncologia Medica Policlinico Gemelli0 个研究点目标入组 600 人开始时间: 2014年11月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Histologically proven diagnosis of colorectal adenocarcinoma;
- •- Diagnosis of metastatic disease;
- •- RAS and BRAF wild-type;
- •- Measurable disease according to RECIST criteria v1.1;
- •- Male or female pts > 18 years of age;
- •- ECOG Performance Status = 2;
- •- Life expectancy of at least 3 months;
- •- Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment;
- •- If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment;
- •- If female and of childbearing potential, or if male, agreement to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method);
- •- Signed informed consent obtained at screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •- Any contraindication to use cetuximab, irinotecan, 5-FU or folinic acid
- •- Active uncontrolled infections or active disseminated intravascular coagulation
- •- Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- •- Pregnancy.
- •- Breastfeeding.
- •- Grade III or IV heart failure (NYHA classification)
- •- Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study
- •- Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
- •- Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
- •- Previous chemotherapy for colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
- •- Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study
- •- Known or clinically suspected brain metastases
- •- History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
- •- Severe, non-healing wounds, ulcers or bone fractures
- •- Uncontrolled hypertension
- •- Marked proteinuria (nephrotic syndrome)
- •- Known DPD deficiency (specific screening not required)
- •- Known history of alcohol or drug abuse
- •- A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
- •- Absent or restricted legal capacity
研究者
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