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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Locally Advanced Cancer in the Anal Region

Intervention / Treatment
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* Drug: Cetuximab
* Drug: Mitomycin C
* Drug: 5-Fluoruracil
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetuximab, Mitomycin C, Fluoruracil<br> | Drug: Cetuximab<br>* Will be given weekly intravenously during study treatment.<br>Drug: Mitomycin C<br>* Will be given intravenously twice together with 5-Fluoruracil during study treatment.<br>Drug: 5-Fluoruracil<br>* Will be given intravenously twice together with Mitomycin C during study treatment<br>Radiation: Radiotherapy<br>* Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish maximum tolerable dose of the two cytotoxic drugs 5-fluoruracil and mitomycin C when given together with the antibody cetuximab and radiotherapy in patients with locally advanced cancer in the anal region |  | Participating patients will be followed during the study period; 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anal cancer, Locally advanced anal cancer, Cetuximab, 5-fluoruracil, Mitomycin C, Radiotherapy