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

NCT ID: NCT01884623

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-06
• Study Completion Date: 2021-10-12

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

Conditions

Head Neck Cancer Squamous Cell Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab

Dosing schedule: 500 mg/m², every two weeks (q2w) Mode of administration: IV

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

Methotrexate

Dosing schedule: 40mg/m2 weekly (q1w) Mode of administration: IV

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

Interventions

Cetuximab

Intervention Type: DRUG

Methotrexate

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Ligue contre le cancer, France

OTHER

Sponsor Role: collaborator

Merck Serono International SA

INDUSTRY

Sponsor Role: collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel GUIGAY, Pr

Role: STUDY_CHAIR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Institut Gustave Roussy

Villejuif, Val De Marne, France

Countries

France

References

Guigay J, Ortholan C, Vansteene D, Cupissol D, Even C, Kaminsky MC, Sire C, Blot E, Debourdeau P, Bozec L, Saada-Bouzid E, Fayette J, Dalloz P, Pointreau Y, Caer HL, Falandry C, Digue L, Braccini A, Lopez S, Guillet P, Michel C, Cheurfa N, Schwob D, Bourhis J, Mertens C, Auperin A; ELAN Group including Gustave Roussy, Unicancer GERICO and H&N groups and the GORTEC. Cetuximab versus methotrexate in first-line treatment of older, frail patients with inoperable recurrent or metastatic head and neck cancer (ELAN UNFIT): a randomised, open-label, phase 3 trial. Lancet Healthy Longev. 2024 Mar;5(3):e182-e193. doi: 10.1016/S2666-7568(23)00284-2.

Reference Type: DERIVED

PMID: 38432247 (View on PubMed)

Other Identifiers

2012/1937

Identifier Type: OTHER

Identifier Source: secondary_id

2012-004967-38

Identifier Type: -

Identifier Source: org_study_id