Phase I/II study of oxaliplatin combined with melphalan in isolated hepatic perfusion for the treatment of liver metastases. - Oxaliplatin combined with melphalan in IHP.

eiden University Medical Center0 个研究点开始时间: 2006年9月28日最近更新: 2012年3月19日

试验速览

暂无简介。

•- Livermetastases of histologically confirmed colorectal adenocarcinoma and for the phase I also livermetastases from solid tumors other than colorectal carcinoma.
•- Resection of primary tumor > 1 month prior to IHP
•- Irresectabel metastes confined to the liver.
•- Measurable metastases on CT-scan
•- Informed consent
•- Life expectancy > 4 months
•- Leukocytes = 3.0 X 109/L
•- Thrombocytes = 100 X 109/L
•- Clearance = 40 ml/min
•- Bilirubin <17 µmol/L
•- APTT < 32.5 sec
•- PT < 13.7 sec
•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) no
•F.1.3.1 Number of subjects for this age range

•- Biological age <18 years >65 years
•- WHO performance status larger or equal to 2
•- < 40% viabel liver tissue
•- Vascular anatomy which inhibits the procedure (ie aberrant right or left hepatic artery, severe atherosclerosis, vascular dissections)
•- Simultaneous severe medical problem (ie severe heart/vascular disease, diabetes with nefropathy, active infection and other liver disease)
•- Mental retardation
•- Pregnancy or inadequate anticonception

发起方

eiden University Medical Center