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 July 2017
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

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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

Male or female 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 September 2016.
Information provided to ClinicalTrials.gov by Lund University Hospital.