Overview

This trial is active, not recruiting.

Condition locally advanced cancer in the anal region
Treatments cetuximab, mitomycin c, 5-fluoruracil, radiotherapy
Phase phase 1
Target EGFR
Sponsor Lund University Hospital
Collaborator Merck Sharp & Dohme Corp.
Start date June 2012
End date January 2019
Trial size 21 participants
Trial identifier NCT01621217, NOAC8.Version1

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
cetuximab
Will be given weekly intravenously during study treatment.
mitomycin c
Will be given intravenously twice together with 5-Fluoruracil during study treatment.
5-fluoruracil
Will be given intravenously twice together with Mitomycin C during study treatment
radiotherapy
Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.

Primary Outcomes

Measure
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
time frame: Participating patients will be followed during the study period; 8 weeks.

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Anders Johnsson, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Lund University Hospital.