EUCTR2006-000685-36-FR进行中（未招募）1 期
A randomized, open-label phase II studyevaluating the efficacy and safety of FOLFOX-4plus cetuximab versus UFOX plus cetuximab asfirst-line therapy in subjects with metastaticcolorectal cancer - FUTURE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
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
- •Both male and female subjects are eligible for randomization.
- •For inclusion in the study, all of the following inclusion criteria must be fulfilled:
- •Subject has given written informed consent before any study-related activities are carried out
- •Inpatient or outpatient =18 years of age
- •Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum
- •First occurrence of metastatic disease (at presentation not curatively resectable)
- •Presence of at least one lesion unidimensionally measurable by CT- and/or MRI-scans. (target lesion(s) must not lie within an irradiated area)
- •Life expectancy of =3 months
- •Karnofsky performance status of =60 at study entry
- •White blood cell count (WBC) =3 x 10^9/L, with neutrophils =1.5 x 10^9/L, platelets =100 x 10^9/L, and hemoglobin =9 g/dL
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x upper limit of normal range (ULN) (<5 x ULN if liver metastasis are present)
- •Normal serum creatinine (in case of elevated creatinine, labeled EDTA (ethylenediaminetetraacetic acid) clearance =65mL/min is acceptable)
- •Effective contraception for both male and female subjects if the risk of conception exists
- •Tumor biopsy or archived tumor sample available
- •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
- •Subjects are not eligible for this study if they fulfill one or more of the following exclusion criteria:
- •Brain metastasis and/or leptomeningeal disease (known or suspected)
- •Previous chemotherapy for CRC except adjuvant treatment with progression of disease documented >6 months after end of adjuvant treatment
- •Previous oxaliplatin-based chemotherapy
- •Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization
- •Concurrent or previous chronic systemic immune therapy, targeted therapy, anti-VEGF therapy, or EGFR-pathway targeting therapy not indicated in the study protocol
- •Concurrent hormonal therapy not indicated in the study protocol except for physiologic replacement or contraception
- •Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
- •Peripheral neuropathy >grade 1
- •Known hypersensitivity reaction to any of the components of the treatment
- •Any concurrent malignancy other than basal cell cancer of the skin, or pre-invasive cancer of the cervix (subjects with a previous malignancy but without evidence of disease for =5 years will be allowed to enter the study)
- •Pregnancy (absence to be confirmed by beta-human choriongonadotrophin [ß-hCG] test) or lactation period
- •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 subject to complete the study or sign meaningful informed consent
- •Participation in another clinical study within the 30 days before randomization
- •Significant disease which, in the investigator’s opinion, would exclude the subject from the study
研究者
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