Open-label randomized, parallel group, phase III, multicenter trial comparing two different sequences of therapy (irinotecan/cetuximab followed by fluorouracil/leucovorin with oxaliplatin (FOLFOX-4) vs. FOLFOX-4 followed by irinotecan/cetuximab) in metastatic colorectal patients treated with fluorouracil/leucovorin with irinotecan (FOLFIRI)/bevacizumab as first line chemotherapy - COMETS [COlorectal Metastatic Two Sequences]

GISCAD0 个研究点开始时间: 2008年2月11日最近更新: 2012年3月19日

研究概览

暂无简介。

•Age >18 < 75 years of age
•Diagnosis of histologically proven adenocarcinoma of the colon or rectum, stage IV
•ECOG performance status 0-1 at study entry
•Neutrophils ≥ 1.5 x 109 /uL, platelets ≥ 100 x 109/uL, and hemoglobin ≥ 9 g/dL
•Bilirubin level either normal or < 1.5 x ULN
•ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present)
•Serum creatinine < 1.5 x ULN
•Effective contraception for both male and female patients if the risk of conception exists
•Life expectancy of ≥ 3 months
•Signed written informed consents
•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

•History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
•Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
•History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake
•Known grade 3 or 4 allergic reaction to any of the components of the treatment
•Known drug abuse/ alcohol abuse

发起方

GISCAD