Clinical trial NCT00202787 (phase 2, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: folfox-4+cetuximab, folfox-4
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent.

          -  Men and women < 75 years

          -  Histologically confirmed diagnosis of CRC

          -  Metastatic colorectal carcinoma with exclusive non-resectable hepatic metastases, due
             to fulfillment of one of the following criteria:

               1. Number of hepatic metastases > or= 4;

               2. Size of one or more hepatic metastases > 5 cm diameter;

               3. Vascular involvement and/or poor site that prevent complete resection of hepatic
                  disease and/or require resection with the remaining liver mass less than 25-30%
                  of functional liver.

          -  Presence of at least one lesion detectable by two-dimensional measurement.

          -  Karnofsky functional status >or=70% at the time of enrollment in study

          -  Life expectancy greater than 3 months.

          -  Patients must not have received chemotherapy for advanced/metastatic disease.

          -  Patients with the following characteristics will be enrolled:

               1. Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or
                  capecitabine +/- radiotherapy with disease-free period > 6 months following
                  conclusion of treatment.

               2. Recurrence after surgical and/or radiotherapy treatment without adjuvant systemic
                  treatment.

               3. De novo diagnosis of disease.

          -  Proper liver function, defined by aspartate aminotransferase (AST/SGOT) and alanine
             aminotransferase (ALT/SGPT) < or = 2.5 x ULN (< or = 5 x ULN if there are hepatic
             metastases) and total bilirubin count < 1.5 x ULN.

          -  Proper kidney function, defined as serum creatinine < 1.5 x ULN.

          -  Proper hematological function, defined as neutrophil count > or = 1.5 x 109/l ,
             platelets > or = 100 X 109/l and hemoglobin > or = 9 g/dl.

          -  Effective birth control method for men as well as women if there is possibility of
             pregnancy

        Exclusion Criteria:

          -  Documented or suspected cerebral and/or leptomeningeal metastases.

          -  Metastasis in any other non-hepatic site, including extrahepatic lymph node
             metastases.

          -  Surgery (excluding biopsy for diagnosis) and/or radiotherapy within 4 weeks prior to
             enrollment in the study.

          -  Participation in another clinical trial with medication in the past 30 days.

          -  Chronic, concomitant administration of systemic immunotherapy, chemotherapy, hormone
             therapy or any other investigational drug.

          -  Prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or
             pre-invasive cervical carcinoma.

          -  Any investigational drug during the 4 weeks prior to enrolment.

          -  Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or
             EGFR-targeted treatment.

          -  Prior participation in study in which treatment with cetuximab can be assigned
             (whether or not treatment with cetuximab is received)

          -  Acute or subacute intestinal occlusion or history of inflammatory intestinal disease.

          -  Evidence of grade 3 or 4 allergic reaction to any of the treatment components.

          -  Clinically relevant peripheral neuropathy.

          -  Clinically relevant myocardial disease or history of myocardial infarction in the past
             12 months.

          -  Known abuse of alcohol / drugs, Legal incapacity or limited legal capacity.

          -  Any medical or psychological disorder which, in the opinion of the investigator, does
             not allow the patient to conclude the study or sign the informed consent.

          -  Pregnant or nursing woman