EUCTR2017-004413-98-ES进行中（未招募）1 期
Phase II clinical trial of doxycycline 50 mg or 100 mg daily for the prevention of skin toxicity in patients with metastatic colorectal cancer treated with panitumumab and chemotherapy
Fundación CRIS0 个研究点目标入组 34 人开始时间: 2018年1月25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
- 34
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
- •1) Male or female of at least 18 years of age
- •2) Able to understand, sign and date an informed consent approved by a Research Ethics Committee with medicines (CEIm)
- •3) Adenocarcinoma of the colon or rectum histologically confirmed in patients with initially unresectable metastatic cancer (M1)
- •4) Confirmation, in the local institution, of RAS tumor not mutated before inclusion in the study
- •5) Patients with a treatment plan based on FOLFOX + panitumumab or FOLFIRI + panitumumab, as first-line treatment of CCRm
- •6) Functional status according to the ECOG (Eastern Cooperative Oncology Group) scale =2
- •7) Acceptable function of the bone marrow: neutrophils =1.5 × 109 / l; platelets =100 × 109 / l; hemoglobin =9 g / dl
- •8) Liver, renal and metabolic function as follows:
- •- Total bilirubin =1,5 ??times the upper limit of normal (ULN), ALT and AST <5 x ULN
- •- Renal function, calculated as creatinine clearance or creatinine clearance of 24 hours, =50 ml / min
- •- Magnesium> lower limit of normality (LIN)
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. History of metastasis or concomitant metastasis in the central nervous system (CNS)
- •2. History of another primary cancer, with the exception of the following: cervical cancer in situ treated with curative intent, non-melanoma skin cancer resected with curative intent or another solid primary tumor treated with curative intent with no known active cancer or treatment administered for at least 5 years before the start of treatment
- •3) Known hypersensitivity to tetracyclines
- •4) Chemotherapy or other previous systemic antineoplastic treatment to treat CCRm
- •5) Previous adjuvant chemotherapy for colorectal cancer completed less than 6 months before diagnosis of metastasis
- •6) Unresolved toxicities of a previous systemic treatment that, in the opinion of the researcher.
- •7) Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g., cetuximab), anti- vascular endothelial growth factor (VEGF) or treatment with small molecule EGFR inhibitors (e.g., erlotinib)
- •8) Prior hormonal therapy, immunotherapy or approved or experimental antibody/proteins =30 days before inclusion
- •9) Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia
- •10) History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computed tomography (CT)
- •11) Treatment for systemic infection within 14 days before the start of study treatment
- •12) Acute or subacute intestinal occlusion and/or active inflammatory bowel disease or other bowel disease that causes chronic diarrhoea (defined as grade = 2 diarrhoea according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.03)
- •13) Clinically significant peripheral sensory neuropathy
- •14) Evidence of previous acute hypersensitivity reaction, of any grade, to any component of the treatment
- •15) History of Gilbert disease or known dihydropyrimidine deficiency syndrome
- •16) Recent gastroduodenal ulcer to be active or uncontrolled
- •17) Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
- •18) Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
- •19) Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery
- •20) History of any disease that may increase the risks associated with study participation or may interfere with the interpretation of study results.
- •21) Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
- •22) Any disorder that compromises the patient’s ability to provide written informed consent and/or comply with study procedures
- •23) Any investigational agent within 30 days prior to inclusion
- •24) Pregnant or breastfeeding woman
- •25) Surgery (excluding diagnostic biopsy or placement of a central venous catheter) and/or radiotherapy within 28 days prior to inclusion in the study.
- •26) Male or female of childbearing age who do not agree with taking adequate contraceptive precautions, i.e. use contraception double barrier (e.g. diaphragm plus condoms) or abstinence during the course of the study and for 6 months after the last administration of study drug for women and 1 month for men
- •27) The patient is unwilling or unable to meet the requirements of the study. Psychological, geographical, familial or sociologica
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