PHARMACOGENOMIC AND PHARMACOKINETIC SAFETY AND COST-SAVING ANALYSIS IN PATIENTS TREATED WITH FLUOROPYRIMIDINES

KI-AV0 个研究点目标入组 500 人开始时间: 2007年2月14日最近更新: 2012年3月19日

试验速览

暂无简介。

•1.Histological or cytological proof of cancer
•2.Patient is considered for treatment with capecitabine or 5-FU
•3.Age 18 years
•4.Able and willing to give written informed consent
•5.Able and willing to undergo blood sampling for pharmacogenetic and pharmacokinetic analysis
•6.Life expectancy ? 3 months allowing adequate follow up of toxicity evalution and antitumor activity
•7.Minimal acceptable safety laboratory values
•a.ANC of 1.5 x 109 /L
•b.Platelet count of ? 100 x 109 /L
•c.Hepatic function as defined by serum bilirubin ? 1.5 x ULN, ALT and AST ? 2.5 x ULN; in case of liver metastases ALT and AST = 5 ULN
•d.Renal function as defined by serum creatinine ? 1.5 x ULN or creatinine clearance ? 50 ml/min (by Cockcroft-Gault formula).
•8.WHO performance status of ? 2
•9.No radio- or chemotherapy within the last 3 weeks prior to 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

•1.Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up
•2.Women who are pregnant or breast feeding
•3.Women of childbearing potential who refuse to use a reliable contraceptive method throughout the study

发起方

KI-AV