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

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

• 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cetuximab; Fluorouracil; Mitomycin; Mitomycins

Criteria

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