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 (NOAC8)

Lund University Hospital

Status and phase

Completed

Phase 1

Conditions

Locally Advanced Cancer in the Anal Region

Treatments

Radiation: Radiotherapy

Drug: Cetuximab

Drug: 5-Fluoruracil

Drug: Mitomycin C

Study type

Interventional

Funder types

Other

Industry

Identifiers

NOAC8.Version1

Details and patient eligibility

About

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

Enrollment

21 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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