Open, randomized, controlled, multicenter phase III study comparing 5-FU/FA plus irinotecan plus cetuximab versus 5-FU/FA plus irinotecan as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer. - CRYSTA

Merck KGaA0 个研究点目标入组 1,300 人开始时间: 2005年2月11日最近更新: 2012年6月26日

适应症

试验速览

暂无简介。

•Inpatient or outpatient =18 years of age
•Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
•Inoperable metastatic disease
•Immunohistochemical evidence of epidermal growth factor receptor Expression in tumor tissue
•Life expectancy of at least 12 weeks
•Presence of at least 1 bi-dimensionally measurable index lesion (not lie in an irradiated area)
•ECOG performance status of =2 at study entry
•Effective contraception for both male and female patients if the risk of conception exists
•White blood cell count =3 x 10E9/L with neutrophils =1.5 x 10E9/L, platelet count =100 x 10E9/L, hemoglobin =5.6 mmol/L (9 g/dL)
•Total bilirubin =1.5 x upper reference range·
•AST =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

•Previous exposure to epidermal growth factor targeting therapy
•Previous irinotecan-based chemotherapy
•Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated >6 months before the start of treatment in this study
•Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of treatment in this study
•Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol
•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 (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 preinvasive cancer of the cervix.

发起方