Phase I/II study of oxaliplatin combined with melphalan in isolated hepatic perfusion for the treatment of liver metastases.
- Conditions
- liver metastasessecondary liver tumours10017991
- Registration Number
- NL-OMON30309
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
- 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
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Determination of the maximum tolerated dose (MTD) , dose limiting toxicity<br /><br>(DLT) and farmacokinetics in IHP with sequential administration of oxaliplatin<br /><br>and melphalan<br /><br>-Determination of phase II doses of oxaliplatin and melphalan.</p><br>
- Secondary Outcome Measures
Name Time Method <p>-Evaluation of toxicity (CTCAE version 3.0), tumor response and survival after<br /><br>IHP with sequential administration of oxaliplatin and melphalan at the MTD<br /><br>previously determined.</p><br>