Cetuximab in combination with weekly 5-fluorouracil/folinic acid and oxaliplatin (FUFOX) in untreated patients with advanced colorectal cancer: a phase Ib/II study of the AIO GI Group.

Abstract Background This two-part phase Ib/II study investigated the feasibility of administering cetuximab in combination with oxaliplatin and infusional 5-fluorouracil (5-FU)/folinic acid (FA) in a weekly schedule (AIO FUFOX protocol) as first-line treatment in patients with epidermal growth factor receptor-detectable advanced colorectal cancer. Patients and methods Cetuximab was administered weekly: 400 mg/m2 initial dose, then 250 mg/m2 and FUFOX: oxaliplatin 50 mg/m2, FA 500 mg/m2 and 5-FU as a 24-h infusion at either 1500 or 2000 mg/m2 administered for 4 weeks followed by a 1-week rest (one cycle). Results Dose-limiting toxicity (grade 3 diarrhea) occurred in 3 of 14 assessable patien…