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 investigational agent within 30 days before enrolment
* Surgery (excluding diagnostic biopsy or central venous catheter placement) and/or radiotherapy within 28 days prior to inclusion in the study