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.
Conditions
Interventions
Trade Name: Eloxatin
Pharmaceutical Form: Powder for infusion*
Trade Name: Alkeran
Pharmaceutical Form: Powder for infusion*
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Biological age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Firstly, determination of the maximum tolerated dose (MTD) , dose limiting toxicity (DLT) and farmacokinetics in IHP with sequential administration of oxaliplatin and melphalan. ;Secondary Objective: Secondly, evaluation of toxicity, tumor response and survival after IHP with sequential administration of oxaliplatin and melphalan at the MTD previously determined.;Primary end point(s): - Determination of the maximum tolerated dose (MTD) , dose limiting toxicity (DLT) and farmacokinetics in IHP with sequential administration of oxaliplatin and melphalan -Determination of phase II doses of oxaliplatin and melphalan. | — |
Countries
Netherlands
Outcome results
None listed