EUCTR2005-005154-44-DE进行中（未招募）不适用
OPERA: OXALIPLATIN AND CETUXIMAB IN FIRST-LINE TREATMENT OF mCRCOpen, non-controlled, multicenter phase II study evaluating 5-FU/FA plus oxaliplatin (FOLFOX-4) plus cetuximab as first-line treatment for patients with undetectable EGFR-status in metastatic colorectal cancer. - OPERA
niversitätsklinikum Hamburg-Eppendorf0 个研究点目标入组 70 人开始时间: 2005年11月11日最近更新:
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
- 70
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 consents
- •Inpatient or outpatient =18 years of age
- •Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- •1st occurrence of metastatic disease (not curatively resectable)
- •EGFR-negative tumour
- •Life expectancy of at least 12 weeks
- •Presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area)
- •ECOG performance status of = 2 at study entry
- •Effective contraception for both male and female subjects if the risk of conception exists
- •White blood cell count (WBC) = 3x10^9/L with neutrophils = 1.5x109/L, platelet count = 100x10^9/L, hemoglobin = 6.21 mmol/L (10 g/dL)
- •ASAT and ALAT = 2.5 x upper reference range, or = 5 x upper reference range in case of liver metastasis
- •Serum creatinine = 1.5 x upper reference range
- •Recovery from relevant toxicity to previous treatment before study entry
- •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
- •Previous exposure to epidermal growth factor receptor-targeting therapy
- •Previous oxaliplatin-based chemotherapy
- •Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
- •Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before inclusion.
- •Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol except physiologic replacement
- •Known hypersensitivity reaction to any of the components of study treatments
- •Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
- •Brain metastasis and/or leptomeningeal disease (known or suspected)
- •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
- •Previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix
- •Known alcohol or drug abuse
- •Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
- •Participation in another clinical study within the 30 days before registration.
- •Significant disease which, in the investigator’s opinion, would exclude the subject from the study
- •Peripheral neuropathy > grade 1
- •Legal incapacity or limited legal capacity
研究者
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