Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer

Inclusion Criteria

• •Subjects must have signed an approved informed consent.
• •Histologically confirmed diagnosis of advanced adenocarcinoma of the colon or rectum, with KRAS wild type on mutational analysis.
• •No prior chemotherapy for metastatic disease (chemotherapy naive). Prior adjuvant therapy with 5FU/LV or IFL (irinotecan, fluorouracilis, and leucovorin (folinic acid)) permitted if completed at least six months prior to entering this study.
• •Measurable disease by RECIST criteria as defined in Section 3.3.1.
• •Subjects for whom tumor tissue is available for IHC ( Immunohistochemistry) testing for EGFR expression.
• •ECOG (Eastern Cooperative Oncology Group) Performance Status 0-1.
• •Recovery in full from any previous surgical procedure.
• •Expected survival greater than 12 weeks.
• •Subjects at least 18 years of age.
• •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
• •Adequate hematologic function defined by an absolute neutrophil count (ANC) \> 1,500/mm3, a platelet count \> 100,000/mm3 .
• •Adequate hepatic function defined by a total bilirubin level no greater than 2.0 times the upper limit of normal (ULN) and AST (Aspartate Aminotransferase) and ALT (alanine transaminase) levels noo greater than 2.5 times the ULN (AST and ALT levels no greater than 5 times the ULN in the presence of liver metastases).
• •Adequate renal function defined by a serum creatinine level no greater than 1.5 times the ULN.