Significance of COX-2 inhibition in first line treatment of extensive disease small-cell lung cancer (ED-SCLC) - COX-2I trial

IVERSITY CLINIC GOLNIK0 个研究点目标入组 60 人开始时间: 2012年9月17日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•The study population will consist of patients aged 18 years and older with chemonaive, cytologicaly/histologicaly proven ED-SCLC.
•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 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•Patients not understanding the disease and no signed written informed consent
•Life expectancy less than 12 weeks
•Other malignant disease except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, or less than 3 years after treatment of other malignant disease
•Known hypersensitivity to acetylsalicylic acid, selective COX-2 inhibitors, other NSAIDs, or sulfonamides
•active ulcer disease
•ECOG PS more than 2
•One or more of the following cardiovascular conditions within the past 6 months:
•- Myocardial infarction
•- Cerebrovascular accident or transient ischemic attack
•- Pulmonary embolism
•- Unstable angina
•- Symptomatic congestive heart failure or congestive heart failure NYHA III-IV
•- Uncontrolled cardiac arrhythmia
•- Uncontrolled hypertension
•- Symptomatic carotid artery or peripheral vascular disease
•- Deep vein thrombosis
•- Other significant thromboembolic events
•Abnormal organ as defined below:
•-severe hepatic dysfunction (AST/ALT> 5 x ULN, bilirubin > 4xUNL, serum albumine < g/L
•-estimated creatinine clearance < 30 mL/min
•Other contraindication for PE/CEV/CAV treatment
•Pregnancy or breastfeeding
•Concomitant fluconazol treatment
•Galactose intolerance

发起方

IVERSITY CLINIC GOLNIK