- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01884623
Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer (ELAN-UNFIT)
February 7, 2024 updated by: Gustave Roussy, Cancer Campus, Grand Paris
Multicentric Randomized Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer in Elderly Unfit Patients According to Geriatric Evaluation
To test whether cetuximab improves efficacy/tolerance as compared to methotrexate in first line treatment of unfit patients ³ 70 years old with recurrent and /or metastatic HNSCC.
Efficacy assessed by failure free survival
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 3
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
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Val De Marne
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Villejuif, Val De Marne, France, 94805
- Institut Gustave Roussy
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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
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients aged 70 or over
- Included in ELAN-ONCOVAL study and considered as "Unfit" by geriatric evaluation done in this study
- PS < 3
- Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, hypopharynx, larynx.
- Recurrence and/or metastatic disease not suitable for local therapy.
- At least one measurable lesion (RECIST 1.1) by CT or MRI.
- No brain metastasis.
- Clearance of creatinine >= 50ml/mn (MDRD).
- Adequate haematological functions defined as follows: absolute neutrophil count > 1.5 x 109/l, platelet > 100 x 109/l, hemoglobin >= 9.5 g/dl
- Adequate hepatic functions with serum total bilirubin <1.25 Upper limit of normal range (ULN); SGOT/SGPT < 5 ULN; AP < 5 ULN
- Life expectancy > 12 weeks.
- Males of reproductive potential must agree to use an effective contraceptive method during the treatment and after the end of treatment during five months.
- Signed informed consent.
- Affiliated to Health Insurance regimen (according to Public Health Law of August 9, 2004).
Exclusion Criteria:
- Included in ELAN-ONCOVAL study and considered as "Fit" by geriatric evaluation
- Patients with nasopharyngeal cancer, paranasal sinus, or cervical lymph nodes metastasis of unknown origin.
- Prior systemic chemotherapy for the squamous cell carcinoma of head and neck, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry.
- Prior anti-EGFR therapy, except if given in association with radiotherapy for squamous cell carcinoma of head and neck which was completed more than 12 months prior to study entry.
- Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before study entry.
- Brain metastasis
- Active infection including tuberculosis and HIV infection.
- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias
- Concomitant immunotherapy or antitumoral hormonotherapy.
- Requirement for treatment with any of the prohibited concomitant medications listed in SPC of Cetuximab and Methotrexate. In particular, acetylsalicylic acid used at analgesic, antipyretic or anti-inflammatory doses (see Section 6.3.2).
- Malignancies within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
- Known allergic hypersensitivity to cetuximab or known positive results of tests for IgE antibodies against cetuximab (α-1-3-galactose) and/or methotrexate or any of their excipients.
- Other severe acute or chronic psychiatric or medical condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this 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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cetuximab
Dosing schedule: 500 mg/m², every two weeks (q2w) Mode of administration: IV
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Active Comparator: Methotrexate
Dosing schedule: 40mg/m2 weekly (q1w) Mode of administration: IV
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Failure free survival (FFS)
Time Frame: From randomization to the first event among progression, treatment stop, whatever the cause, loss of 2 points or more in ADL scale and death assessed up to 16 months
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Composite criteria of efficacy and tolerance: Failure free survival (FFS) defined as time from randomization to the first event among progression (defined by RECIST criteria), treatment stop (whatever the cause), loss of 2 points or more in Activities in Daily Living (ADL) scale and death (whatever the cause).
Patients who don't have any of these events are censored at the date of last follow-up.
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From randomization to the first event among progression, treatment stop, whatever the cause, loss of 2 points or more in ADL scale and death assessed up to 16 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: From randomization to death from any cause assessed up to 1 months
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Patients with disease progression will be treated off protocol but will be followed for overall survival evaluation.
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From randomization to death from any cause assessed up to 1 months
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Progression free survival (PFS)
Time Frame: From randomization to progression assessed up to 16 months
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minimum time from randomization to progression as defined by RECIST criteria or to death from any cause.
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From randomization to progression assessed up to 16 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Joel GUIGAY, Pr, Gustave Roussy, Cancer Campus, Grand Paris
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)
November 6, 2013
Primary Completion (Actual)
October 12, 2021
Study Completion (Actual)
October 12, 2021
Study Registration Dates
First Submitted
June 18, 2013
First Submitted That Met QC Criteria
June 20, 2013
First Posted (Estimated)
June 24, 2013
Study Record Updates
Last Update Posted (Estimated)
February 9, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Disease Attributes
- Head and Neck Neoplasms
- Recurrence
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
- Cetuximab
Other Study ID Numbers
- 2012-004967-38
- 2012/1937 (Other Identifier: CSET number)
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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