Study of Xeloxiri Regimen for Patients With Refractory Metastatic Colorectal Cancer

Inclusion Criteria: * Adults ≥ 18 years of age, male or female. * Histopathologically or cytologically confirmed adenocarcinoma. * Failed ≥ 2 lines of standard therapy which must include a fluoropyrimidine, oxaliplatin and/or irinotecan, administered either as monotherapy or doublets. * ECOG performance status 0 to 2. * Adequate bone marrow reserve. * Absolute neutrophil count \> 1 × 109/L. * Total bilirubin \< 3 × the upper limit of the normal range. * Life expectancy ≥ 12 weeks. * Signed written informed consent form. Exclusion Criteria: * Prior malignant disease other than colorectal cancer within 5 years of study entry. * Patients suitable for surgical or locoregional therapies. * Patients unable to swallow oral medications. * Any evidence of brain metastasis (unless the patient is \>6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry). * Active clinically serious infections (\> grade 2 NCI / CTC Adverse Event version 3.0). * History of allergy to platinum compounds. * Patients who have chronic inflammatory bowel disease and/or bowel obstruction. * Patients who have severe bone marrow failure. * Patients undergoing renal dialysis. * History of HIV infection. * Seizure disorder requiring medication (such as steroids or anti-epileptics). * Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception. * Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.