EUCTR2014-001422-16-GR进行中（未招募）1 期
An open label, non-randomized, phase two trial in metastatic colorectal cancer (mCRC) with the combination of mFOLFIRI plus Aflibercept as first treatment: MINOAS trial - MINOAS
Hellenic Oncology Research Group0 个研究点目标入组 50 人开始时间: 2015年9月21日最近更新:
适应症
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
- 50
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
- •Patients with histologically documented adenocarcinomas of colon or rectum with unresectable metastatic disease.
- •No prior treatment for metastatic disease
- •Metastatic liver disease assessable with diffusion-weighted MR Imaging.
- •No previous treatment with bevacizumab or Cetuximab or Panitumumab.
- •Patients may have receive fluoropyrimidines with or without oxaliplatin as adjuvant treatment, if they have progressed > 12 months after the end of the last cycle of the adjuvant treatment
- •Performance Status (ECOG) 0-2
- •Life expectancy = 3 months.
- •Effective contraception for both male and female subjects if the risk of conception exists.
- •Adequate laboratory parameters: Absolute neutrophils count = 1.5 x 109 /L, Platelets = 100 x 109 /L, Leucocytes > 3,000/mm; Hemoglobin> 10.5g/dl, creatinine clearance = 60 ml/min, Proteinuria <2+ (dipstick urinalysis) or =1g/24hour, Magnesium = lower limit of normal, Calcium = lower limit of normal, total Bilirubin = 1.5 times the upper limit of normal; aspartate and alanine aminotransferase = 3 times of the upper normal limit in absence of liver metastases, or =5xUNL in presence of liver metastases, alkaline phosphatases < 5xULN
- •All patients will have to sign written informed consent in order to participate in the study.
- •Female patients must commit to using reliable and appropriate methods of contraception until at least three months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another contraceptive method during the trial
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Known hypersensitivity reaction to the component of the treatment.
- •Inability to underwent a diffusion-weighted MR Imaging at baseline and in predefined time points
- •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy),
- •Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
- •Treatment with any other investigational medicinal product within 28 days prior to study entry.
- •Other serious and uncontrolled non-malignant disease
- •Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy.
- •Gilbert's syndrome
- •Intolerance to atropine sulfate or loperamide
- •Known dihydropyrimidine dehydrogenase deficiency
- •Treatment with CYP3A4 inducers unless discontinued > 7 days prior to randomization
- •Any of the following in 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis
- •Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days
- •INR in absence of anticoagulation therapy > 1.25 or poorly controlled anti-coagulation therapy on coumadin or heparin compounds (INR >3.0)
- •History of myocardial infarction and/or stroke within 6 months prior to randomization, NYHA class III and IV congestive heart failure
- •History of life threatening (grade 4) venous thromboembolic events (including pulmonary embolism) within 6 months prior to registration,
- •Bowel obstruction
- •Legal incapacity or limited legal capacity.
- •Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent.
- •A second primary tumour other than non-melanoma skin cancer or in situ cervical cancer.
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on chest CT scan.
研究者
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