|• Signed written informed consent.|
|• Male or female.|
|• At least 18 years of age.|
|• Female patients of childbearing potential (and if appropriate male patients with female partners of childbearing potential) must be willing to use an adequate method of contraception for 4 weeks prior to, during and 12 weeks after the last dose of trial medication. A negative pregnancy test is required for female subjects. Adequate contraception for female subjects is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device or use of hormonal female contraceptive. For the purpose of this trial, women of childbearing potential are defined as: "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive."|
|• Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with complete resection of primary tumor and no evidence of local relapse.|
|• Metastatic disease of the liver, with recent (< 6 weeks prior to randomization) resection (R0 or R1) of all liver metastases. Metastasectomy may have been either synchronous or metachronous. Any neoadjuvant therapy may have been applied for maximal 3 months prior to metastasectomy.|
|• Subject has had a colonoscopy or rectoscopy within the last three months prior to initiation of therapy|
|• Subject has an ECOG performance status of 0 or 1.|
|• Subject has adequate hematologic, hepatic, and renal function within 2 weeks prior to initiation of therapy as defined by the following:|
- Absolute neutrophils > 1,500/mm3 and platelets > 140,000/mm3.|
- Bilirubin < 1.5 × upper limit of normal (ULN).
- AST and ALT < 2.5 × ULN.
- Creatinine < 1.5 × ULN.
- International Normalized Ratio (INR) and partial thromboplastin time (PTT) in the normal range of the local lab.
|• Willingness to comply with study protocol requirements.|