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

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

• To establish maximum tolerated dose of the two cytotoxic drugs 5-fluoruracil and mitomycin C when given together with the antibody cetuximab in patients with locally advanced cancer in the anal region
• To evaluate acute toxicity
• To evaluate late toxicity
• To evaluate response rate
• To evaluate recurrence free survival
• To evaluate overall survival

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