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

NCT01621217 | Completed Phase 1

• 1 other identifier: NOAC8.Version1
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 3

Brief 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

Conditions

Locally Advanced Cancer in the Anal Region

Keywords

Anal cancer; Locally advanced anal cancer; Cetuximab; 5-fluoruracil; Mitomycin C; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  Participating patients will be followed during the study period; 8 weeks.

Study Arms (1)

Cetuximab, Mitomycin C, Fluoruracil

EXPERIMENTAL

Drug: Cetuximab; Drug: Mitomycin C; Drug: 5-Fluoruracil; Radiation: Radiotherapy

Interventions

Cetuximab DRUG

Will be given weekly intravenously during study treatment.

Cetuximab, Mitomycin C, Fluoruracil

Mitomycin C DRUG

Will be given intravenously twice together with 5-Fluoruracil during study treatment.

Cetuximab, Mitomycin C, Fluoruracil

5-Fluoruracil DRUG

Will be given intravenously twice together with Mitomycin C during study treatment

Cetuximab, Mitomycin C, Fluoruracil

Radiotherapy RADIATION

Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.

Cetuximab, Mitomycin C, Fluoruracil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

University Hospital, Dept. of Oncology

Oslo, 4950, Norway

Location

Skåne University Hospital, Dept. of Oncology

Lund, 221 85, Sweden

Location

Accademic Hospital, Dept. of Oncology

Uppsala, 751 85, Sweden

Location

Related Publications (1)

• Leon O, Guren MG, Radu C, Gunnlaugsson A, Johnsson A. Phase I study of cetuximab in combination with 5-fluorouracil, mitomycin C and radiotherapy in patients with locally advanced anal cancer. Eur J Cancer. 2015 Dec;51(18):2740-6. doi: 10.1016/j.ejca.2015.08.029. Epub 2015 Nov 18.

  PMID: 26597443 DERIVED

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Cetuximab; Mitomycin; Radiotherapy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• Anders Johnsson, MD, PhD

  Skåne University Hospital, Dept. of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 18, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

NO (1); SE (2)