Phase I Trial of Sorafenib + FOLFIRI In Metastatic Colorectal Cancer

Inclusion Criteria: * Metastatic colorectal cancer * Histopathological verification of the primary tumor * Measurable disease according to RESIST criteria * Response Evaluation Criteria in Solid Tumors (ECOG) performance status ≤ 2 * Age \> 18 years. * Women of childbearing potential must have had a negative pregnancy test within 7 days prior to start of treatment. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. * Patients may have had prior adjuvant chemotherapy with fluoropyrimidines WITHOUT pelvic radiotherapy. * Radiation: Patients may have had prior palliative radiation therapy to NO more than 50% of the areas bearing of bone marrow stores. * Adequate organ and marrow function : Hemoglobin \> 9.0 g/dl; absolute neutrophil count (ANC) \>1,500/mm3; absolute granulocyte count(AGC) \> 1.5 x 109 /L; Platelets \> 100 x 109 /L; Serum creatinine and creatinine clearance within upper normal limit; Bilirubin \< 1.0 x upper normal limit, \< 2.5 x upper normal limit if documented liver metastases; aspartate aminotransferase (AST) \< 2.5 x upper normal limit, \< 5 x upper normal limit if documented liver metastases * Life expectancy \> 3 months * Informed consent Exclusion Criteria: * Previous or concurrent malignancies * Patients with central nervous system (CNS) metastases * Pregnant or lactating women * Concurrent treatment with other experimental drugs or anticancer therapy * Previous chemotherapy for advanced and/or metastatic disease * Previous adjuvant therapy with irinotecan or targeted agents * Previous Sorafenib therapy * Previous full dose curative pelvic radiotherapy * History of cardiovascular disease, cerebral ischemia infarction or hemorrhage, Gilbert's disease, HIV positivity * Unable to be compliant with the procedures in the protocol * Currently use prohibited medications