EUCTR2011-001010-34-AT进行中（未招募）不适用
A randomized, placebo-controlled, double-blind multicenter phase II study to investigate the protectivity and efficacy of Metformin against steatosis in combination with FOLFIRI and Cetuximab in subjects with first-line palliative treated, KRAS-Wild-Type, metastatic colorectal cancer - G-LUCAS
ABCSG (Austrian Breast & Colorectal Cancer Study Group)0 个研究点目标入组 132 人开始时间: 2011年5月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
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
- •Signed written informed consent
- •Male or female >= 18 years of age
- •Diagnosis of histologically confirmed, KRAS wild-type” adenocarcinoma of the colon or rectum
- •Non-resectable metastatic colorectal carcinoma
- •Either presence of at least one liver lesion measurable unidimensionally by CT scan or MRI or at least one resectable liver metastasis with non-resectable extrahepatic disease (as assessed within 3 weeks prior to randomisation)
- •Subjects scheduled to receive cetuximab and FOLFIRI
- •ECOG performance status of 0 - 1 at study entry
- •Leukocytes >= 3.0 x 10^9/L and neutrophils >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, and hemoglobin >= 8 g/dL
- •Bilirubin <= 1.5 x ULN
- •ASAT and ALAT <= 5 x ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 132
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 132
排除标准
- •Brain metastasis (if suspected, brain scan indicated)
- •Previous chemotherapy for the currently existing metastatic disease
- •Known or newly diagnosed diabetes
- •Patients with ACS within the last three months
- •Stage 3 or 4 heart failure defined according to the NYHA criteria
- •Uncontrolled angina
- •Contraindications to metformin (renal impairment [eGFR <45 mL/min/1.73m^2], known hypersensitivity to metformin, acute illness [dehydration, severe infection, shock, acute cardiac failure]), and suspected tissue hypoxia
- •Surgery (excl. diagnostic biopsy, central venous catheter) or irradiation within 2 weeks prior to study entry defined as given written informed consent
- •Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- •Administration of any investigational agent(s) within 4 weeks prior to study entry,
- •Previous exposure to EGFR-pathway targeting therapy
- •Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- •Known grade 3 or 4 allergic reaction to any of the components of the treatment
- •Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Subjects with a previous malignancy but without evidence of disease for >= 5 years will be allowed to enter the trial)
- •Pregnancy or lactation
- •Inadequate contraception (male or female patients) if of childbearing or procreative potential
- •Known drug abuse/ alcohol abuse
- •Legal incapacity or limited contractual capacity
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
研究者
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