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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Lund University Hospital
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT01621217
First received: June 14, 2012
Last updated: April 25, 2014
Last verified: April 2014
  Purpose
  • 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

Condition Intervention Phase
Locally Advanced Cancer in the Anal Region.
Drug: Cetuximab
Drug: Mitomycin C
Drug: 5-Fluoruracil
Radiation: Radiotherapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Lund University Hospital:

Primary Outcome 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 21
Study Start Date: June 2012
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621217

Contacts
Contact: Anders Johnsson, MD, PhD +46 46 17 75 20 anders.johnsson@skane.se
Contact: Jan Sundberg, RN +46 46 17 70 34 jan.sundberg@skane.se

Locations
Norway
University Hospital, Dept. of Oncology Not yet recruiting
Oslo, Norway, 4950
Contact: Marianne Gronlie Guren, MD, PhD    +47 915 027 70    UXARUR@ous-hf.no   
Principal Investigator: Marianne Gronlie Guren, MD, PhD         
Sweden
Skåne University Hospital, Dept. of Oncology Recruiting
Lund, Sweden, 221 85
Contact: Anders Johnsson, MD, PhD    +46 46 17 75 20    anders.johnsson@skane.se   
Contact: Jan Sundberg, RN    +46 46 17 70 34    jan.sundberg@skane.se   
Principal Investigator: Anders Johnsson, MD, PhD         
Accademic Hospital, Dept. of Oncology Recruiting
Uppsala, Sweden, 751 85
Contact: Bengt Glimelius, MD, PhD, professor    +46 18 611 10 00    bengt.glimelius@onkologi.uu.se   
Principal Investigator: Bengt Glimelius, MD, PhD         
Sponsors and Collaborators
Lund University Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Anders Johnsson, MD, PhD Skåne University Hospital, Dept. of Oncology
  More Information

No publications provided

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT01621217     History of Changes
Other Study ID Numbers: NOAC8.Version1
Study First Received: June 14, 2012
Last Updated: April 25, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University Hospital:
Anal cancer
Locally advanced anal cancer
Cetuximab
5-fluoruracil
Mitomycin C
Radiotherapy

Additional relevant MeSH terms:
Anus Neoplasms
Anus Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Rectal Neoplasms
Cetuximab
Mitomycin
Mitomycins
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014