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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • France
    • Val De Marne
      • Villejuif, Val De Marne, France, 94805
        • Institut Gustave Roussy

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cetuximab
Dosing schedule: 500 mg/m², every two weeks (q2w) Mode of administration: IV
Drug: Cetuximab
Active Comparator: Methotrexate
Dosing schedule: 40mg/m2 weekly (q1w) Mode of administration: IV
Drug: Methotrexate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From randomization to death from any cause assessed up to 1 months
Patients with disease progression will be treated off protocol but will be followed for overall survival evaluation.
From randomization to death from any cause assessed up to 1 months
Progression free survival (PFS)
Time Frame: From randomization to progression assessed up to 16 months
minimum time from randomization to progression as defined by RECIST criteria or to death from any cause.
From randomization to progression assessed up to 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gustave Roussy, Cancer Campus, Grand Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute, France
Merck Serono International SA
Ligue contre le cancer, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2013

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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