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

Overview

– 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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2020

Interventions

  • Drug: Cetuximab
    • Will be given weekly intravenously during study treatment.
  • Drug: Mitomycin C
    • Will be given intravenously twice together with 5-Fluoruracil during study treatment.
  • Drug: 5-Fluoruracil
    • Will be given intravenously twice together with Mitomycin C during study treatment
  • Radiation: Radiotherapy
    • Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.

Arms, Groups and Cohorts

  • Experimental: Cetuximab, Mitomycin C, Fluoruracil

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lund University Hospital
  • Collaborator
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anders Johnsson, MD, PhD, Principal Investigator, Skåne University Hospital, Dept. of Oncology

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