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.
- Conditions
- Patients with isolated hepatic metastases of histologically confirmed colorectal adenocarcinoma and for the phase I study also isolated hepatic metastases of all other solid tumors.
- Registration Number
- EUCTR2006-005088-25-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method