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)
Primary Purpose
Locally Advanced Cancer in the Anal Region
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Cetuximab
Mitomycin C
5-Fluoruracil
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Cancer in the Anal Region focused on measuring Anal cancer, Locally advanced anal cancer, Cetuximab, 5-fluoruracil, Mitomycin C, Radiotherapy
Eligibility 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
Sites / Locations
- University Hospital, Dept. of Oncology
- Skåne University Hospital, Dept. of Oncology
- Accademic Hospital, Dept. of Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cetuximab, Mitomycin C, Fluoruracil
Arm Description
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01621217
First Posted
June 14, 2012
Last Updated
February 27, 2020
Sponsor
Lund University Hospital
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01621217
Brief 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
Acronym
NOAC8
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Cancer in the Anal Region
Keywords
Anal cancer, Locally advanced anal cancer, Cetuximab, 5-fluoruracil, Mitomycin C, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cetuximab, Mitomycin C, Fluoruracil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Will be given weekly intravenously during study treatment.
Intervention Type
Drug
Intervention Name(s)
Mitomycin C
Intervention Description
Will be given intravenously twice together with 5-Fluoruracil during study treatment.
Intervention Type
Drug
Intervention Name(s)
5-Fluoruracil
Intervention Description
Will be given intravenously twice together with Mitomycin C during study treatment
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Johnsson, MD, PhD
Organizational Affiliation
Skåne University Hospital, Dept. of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Dept. of Oncology
City
Oslo
ZIP/Postal Code
4950
Country
Norway
Facility Name
Skåne University Hospital, Dept. of Oncology
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Accademic Hospital, Dept. of Oncology
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
26597443
Citation
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.
Results Reference
derived
Learn more about this trial
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
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