Phase I Study of Cetuximab in Combination With 5-fluoruracil, Mitomycin C and Radiotherapy in Patients With Anal Cancer Stage T2 (>4 cm) - T4 N0-3 M0 or Any T N2-3 M0

Inclusion Criteria: * Age over 18 years * Histologically or cytologically confirmed squamous cell cancer of the anal region (anal canal or anal margin or distal rectum) * Stage T2 (≥4 cm) - T4 N0-3 M0 or any T N2-3 M0 * ECOG performance status 0-1 * Hb \> 100 g/L * ANC \> 1.5 x 10 9/L * Platelets ≥ 100 x 10 9/L * Creatinine \< 1.5 x ULN * Bilirubin \< 1.5 x ULN * ALAT \< 3.0 x ULN * Competent to comprehend, sign and date an approved informed consent form Exclusion Criteria: * Previous pelvic irradiation * Previous chemotherapy for anal cancer * Previous malignancy within the last 5 years, except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix uteri * Pregnant or nursing females or patients of child-bearing potential not using adequate methods of birth control * Patients with active infections or any other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment * Known hypersensitivity to any of the components of the treatment * Clinically significant cardiovascular disease, e.g. cardiac failure (\<12 months before treatment start), unstable angina, congestive heart failure, arrythmia requiring medication, or uncontrolled hypertension * Known positive test for hepatitis C virus, chronic active hepatitis B infection * Known HIV infection * Any other condition or therapy which in the investigator´s opinion may pose a risk to the patient or interfere with the study objectives * Any in…