Locally Advanced Cancer in the Anal RegionPhase 1NOAC8NCT01621217
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
A Phase 1 study testing Cetuximab, Mitomycin C and 5-Fluoruracil in people with Locally Advanced Cancer in the Anal Region, run by Lund University Hospital at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Cancer in the Anal Region
- What is being tested?
- Cetuximab, Mitomycin C and 5-Fluoruracil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2012to Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Sweden2 sites
Skåne University Hospital, Dept. of Oncology
Lund, 221 85
Accademic Hospital, Dept. of Oncology
Uppsala, 751 85
About this study
- 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
- Being tested
- Cetuximab, Mitomycin C, 5-Fluoruracil, Radiotherapy
- Keywords
- Anal cancer, Locally advanced anal cancer, Cetuximab, 5-fluoruracil, Mitomycin C, Radiotherapy
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Will be given weekly intravenously during study treatment.
Mitomycin CDrug
Will be given intravenously twice together with 5-Fluoruracil during study treatment.
5-FluoruracilDrug
Will be given intravenously twice together with Mitomycin C during study treatment
RadiotherapyRadiation
Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab, Mitomycin C, Fluoruracil | Experimental | Not described Receives: Drug: Cetuximab; Drug: Mitomycin C; Drug: 5-Fluoruracil; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Participating patients will be followed during the study period; 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Cancer in the Anal RegionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Anders Johnsson, MD, PhD, Principal investigator, Skåne University Hospital, Dept. of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621217
- Sponsor's protocol ID
- NOAC8.Version1
- Acronym
- NOAC8
- Status last verified
- Feb 2020
- First submitted
- 14 Jun 2012
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26597443
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01621217
- Acronym / sponsor ID
- NOAC8 / NOAC8.Version1
- Keywords
- Anal cancer, Locally advanced anal cancer, Cetuximab, 5-fluoruracil, Mitomycin C, Radiotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2012 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab, Mitomycin C, Fluoruracil | Experimental | Drug: Cetuximab, Drug: Mitomycin C, Drug: 5-Fluoruracil, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabWill be given weekly intravenously during study treatment. | Drug | Cetuximab, Mitomycin C, Fluoruracil |
| Mitomycin CWill be given intravenously twice together with 5-Fluoruracil during study treatment. | Drug | Cetuximab, Mitomycin C, Fluoruracil |
| 5-FluoruracilWill be given intravenously twice together with Mitomycin C during study treatment | Drug | Cetuximab, Mitomycin C, Fluoruracil |
| RadiotherapyRadiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions. | Radiation | Cetuximab, Mitomycin C, Fluoruracil |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Derived from this study: PubMed 26597443Leon 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Johnsson, MD, PhD principal investigator
Skåne University Hospital, Dept. of Oncology
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cetuximab, Mitomycin C and 5-Fluoruracil in people with Locally Advanced Cancer in the Anal Region, run by Lund University Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01621217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.