EUCTR2007-000460-24-DE进行中（未招募）1 期
Bi-weekly Cetuximab combined with FOLFOX-6 as first-line treatment in metastatic colorectal cancer patients with wild-type k-ras status - CEBIFOX
niversity of Duisburg-Essen0 个研究点开始时间: 2008年11月21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
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 metastatic colorectal cancer
- •Molecular test showing no mutation in the k-ras gene of colorectal carcinoma cells
- •male and female subjects = 18 years of age
- •1st occurrence of metastatic disease (not curatively resectable)
- •life expectancy = 12 weeks
- •presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area)
- •ECOG performance status = 2 at study entry
- •Adequate bone marrow reserve:
- •leucocytes = 3.0 x 109/l with neutrophils = 1.5 x 109/l,
- •platelets = 100 x 109/l, haemoglobin = 6.21 mmol/l (10 g/dl)
- •ASAT and ALAT = 2.5 x upper reference range, in case of liver metastasis = 5 x upper reference range
- •Serum creatinine = 1.5 x upper reference range
- •Bilirubin = 1.5 x upper reference range
- •Negative pregnancy test for female and effective contraception for both male and female subjects if the risk of conception exists
- •signed written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Evidence for a mutation of the k-ras gene in the colorectal carcinoma cells
- •previous exposure to epidermal growth factor receptor-targeting therapy
- •prior chemotherapy for metastatic disease
- •Oxaliplatin-based adjuvant chemotherapy within 1 year before registration
- •Neuropathy = grade 3 (NCI_CTC V3.0) during prior oxaliplatin-based chemotherapy
- •Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before registration
- •Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol
- •Creatinine clearance < 30 ml/min
- •Known hypersensitivity reaction to any of the components of study treatment
- •pregnancy (absence to be confirmed by ß-hCG test) or lactation period
- •Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
- •Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- •Brain metastasis (known or suspected)
- •Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
- •Known alcohol or drug abuse
- •Participation in another clinical study within the 30 days before registration
- •peripheral neuropathy > grade 1
- •Significant disease which, in the investigator’s opinion, would exclude the patient from the study
- •legal incapacity or limited legal capacity
研究者
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