EUCTR2006-006941-15-LV进行中（未招募）不适用
A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX4 + weekly Cetuximab versus FOLFOX4 + bi-weekly Cetuximab as first-line therapy in patients with metastatic colorectal cancer
CECOG (Central European Cooperative Oncology Group)0 个研究点目标入组 150 人开始时间: 2007年6月8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
- 150
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 at least 18 years of age
- •Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- •Metastatic colorectal carcinoma not suitable for curative-intent resection
- •Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment
- •Presence of at least one lesion measurable unidimensionally by CT scan or MRI (target lesion(s) must not lie within an irradiated area)
- •Karnofsky performance status of > 80 at study entry
- •Leucocytes at least 3.0 x 109/L and neutrophils at least 1.5 x 109/L, platelets at least 100 x 109/L, and hemoglobin at least 9 g/dL
- •Bilirubin not exceeding 1.5 x ULN
- •ASAT and ALAT not exceeding 2.5 x ULN (not exceeding 5 x ULN if liver metastasis are present)
- •Serum creatinine not exceeding 1.5 x ULN
- •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
- •Brain metastasis (known or suspected)
- •Previous chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed if the chemotherapy treatment free interval is > 6 months.
- •Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
- •Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- •Any investigational agent(s) within 4 weeks prior to entry
- •Previous exposure to EGFR-pathway targeting therapy
- •Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
- •Acute or subacute intestinal occlusion or history of inflammatory bowel disease
- •Pre-existing neuropathy > grade 1. In case of prior oxaliplatin containing adjuvant chemotherapy: pre-existing neuropathy of grade 1 or higher.
- •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. (Patients with a previous malignancy but without evidence of disease for at least 5 years will be allowed to enter the trial)
- •Pregnancy or lactation
- •Inadequate contraception (male or female patients) if of childbearing or procreational potential
- •Known drug abuse/ alcohol abuse
- •Legal incapacity or limited legal 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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