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