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 (NOAC8)

February 27, 2020 updated by: Lund University Hospital
  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 4950
        • University Hospital, Dept. of Oncology
  • Sweden
      • Lund, Sweden, 221 85
        • Skåne University Hospital, Dept. of Oncology
      • Uppsala, Sweden, 751 85
        • Accademic Hospital, Dept. of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cetuximab, Mitomycin C, Fluoruracil
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Participating patients will be followed during the study period; 8 weeks.
Participating patients will be followed during the study period; 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Anders Johnsson, MD, PhD, Skåne University Hospital, Dept. of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

June 14, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (Estimate)

June 18, 2012

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOAC8.Version1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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