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Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer (ELAN-UNFIT)

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ClinicalTrials.gov Identifier: NCT01884623
Recruitment Status : Active, not recruiting
First Posted : June 24, 2013
Last Update Posted : August 13, 2018
Sponsor:
Collaborators:
National Cancer Institute, France
Ligue contre le cancer, France
Merck Serono International SA
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Head Neck Cancer Squamous Cell Recurrent Drug: Cetuximab Drug: Methotrexate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 6, 2013
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : August 2023

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Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884623


Locations
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France
Institut Gustave Roussy
Villejuif, Val De Marne, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France
Ligue contre le cancer, France
Merck Serono International SA
Investigators
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Study Chair: Joel GUIGAY, Pr Gustave Roussy, Cancer Campus, Grand Paris

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01884623     History of Changes
Other Study ID Numbers: 2012-004967-38
2012/1937 ( Other Identifier: CSET number )
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Methotrexate
Cetuximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Immunological