Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC

NCT01864772 | Completed Phase 2 DMC

• 1 other identifier: GORTEC ELAN-FIT
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment).

Conditions

Metastatic or Recurrent Head and Neck Squamous Cell Cancer

Keywords

HNSCC; Metastatic; Recurrent; Elderly; Geriatry

Outcome Measures

Primary Outcomes (1)

• Objective response and acute toxicity

  Objective tumor response at 12 weeks, safety (no grade 3, 4, 5 toxicities) and preservation of geriatric autonomy (absence of 2 or more points decrease on the Activities of Daily Living (ADL) scale) 1 month after the end of chemotherapy

  1 month after the end of chemotherapy

Secondary Outcomes (7)

• Best objective tumor response

  6 weeks after the end of treatment

• Overall survival

  1 year after the end of treatment

• progression free survival

  1 year after the end of treatment

• Duration of response under cetuximab maintenance therapy

  1 year after the end of maintenance

• Toxicity of cetuximab maintenance therapy

  3 months after the end of maintenance

Study Arms (1)

Carbo, 5FU, Cetuximab

EXPERIMENTAL

6 cycles (1 cycle = 21 days) of: carboplatin AUC 5, 5FU D1-4 1000mg/m²/d, every 21 days cetuximab weekly (400 mg/m² the first week of treatment and then 250 mg/m²/w) Maintenance by cetuximab 500 mg/m² every 2 weeks until progression or toxicity

Drug: Carbo, 5FU, Cetuximab

Interventions

Carbo, 5FU, Cetuximab DRUG

6 cycles (1 cycle = 21 days) of: carboplatin AUC 5, 5FU D1-4 1000mg/m²/d, every 21 days cetuximab weekly (400 mg/m² the first week of treatment and then 250 mg/m²/w) Maintenance by cetuximab 500 mg/m² every 2 weeks until progression or toxicity

Carbo, 5FU, Cetuximab

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age greater than or equal to 70 years
• patient enrolled in ELAN-ONVOCAL study and evaluated as fit (harmonious aging) by GERICO screening method for geriatric frailty
• life expectancy superior to 12 weeks
• creatinin clearance \> ou equal to 50ml/mn calculated using Modification of Diet in Renal Disease (MDRD) formula
• hematologic function : absolute neutrophil count \> 1.5 x 10\^9/l, platelets \> 100 x 10\^9/l, hemoglobin \> 9,5 g/dl
• liver function : total bilirubin inferior to 1,25 x Upper limit of normal (ULN), SGOT/SGPT inferior to 5 x ULN, PAL inferior to 5 x ULN
• PS \< 2
• The disease:
• histologically proven head and neck squamous cell carcinomas
• recurrent or metastatic. Visceral metastases or locoregional recurrence unsuitable for curative locoregional treatment: unsuitable for primitive tumor surgery due to local extension (evidently authorized for lymph nodes) and unsuitable for radiotherapy for primitive tumor (or already performed) due to metastatic dissemination and the absence of indication for re-irradiation of primitive tumor.
• Presence of at least one measurable lesion (defined by RECIST criteria) by CT scan or IRM
• asymptomatic cerebral metastases authorized
• General:
• signed Informed Consent Form
• affiliated to the French social security system (or a beneficiary of this system) according to the provisions of the law of 9 August 2004

You may not qualify if:

• Previous systemic chemotherapy, except for chemotherapy as part of multimodal treatment for locally advanced cancer completed more than 6 months prior to study enrollment
• Known contraindication specific to one of study treatments (particularly cardiac for 5FU)
• Known dihydropyrimidine dehydrogenase deficiency (DPD deficiency).
• Patients considered as "unfit " (fragile) by GERICO screening method for geriatric frailty
• Irradiation within 4 weeks prior to study enrollment.
• Nasopharyngeal, rhinopharyngeal or maxillary sinus carcinoma.
• Presence of infection (infection requiring intravenous antibiotics), including tuberculosis and HIV infection (human immunodeficiency virus).
• Concomitant treatment with other antitumor immunotherapy or hormonal therapy.
• Other antitumor concomitant therapies.
• Prior treatment with EGFR-targeted therapy (epidermal growth factor receptor).
• Treatment with one of study drugs within 30 days prior to study enrollment.
• Presence of documented symptomatic brain or leptomeningeal metastases
• Clinically significant coronaropathy or antecedent myocardial infarction within 12 months prior to study enrollment or high-risk uncontrolled arrhythmias or uncontrolled heart failure.
• Medically uncontrolled arterial hypertension
• Other prior or concomitant cancer, with exception for carcinoma in situ of the uterine cervix, or for cutaneous basal cell carcinoma within 5 years prior to study enrollment.

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator

Study Sites (2)

Hôpital de la Dracénie

Draguignan, 83300, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

• Guigay J, Le Caer H, Ferrand FR, Geoffrois L, Saada-Bouzid E, Fayette J, Sire C, Cupissol D, Blot E, Guillet P, Pavillet J, Bozec L, Capitain O, Rolland F, Debourdeau P, Pointreau Y, Falandry C, Lopez S, Coutte A, Chatellier T, Dalloz P, Ortholan C, Michel C, Lacas B, Cheurfa N, Schwob D, Bourhis J, Mertens C, Auperin A; ELAN Group including Gustave Roussy, Unicancer GERICO and H&N groups, and GORTEC. Adapted EXTREME regimen in the first-line treatment of fit, older patients with recurrent or metastatic head and neck squamous cell carcinoma (ELAN-FIT): a multicentre, single-arm, phase 2 trial. Lancet Healthy Longev. 2024 Jun;5(6):e392-e405. doi: 10.1016/S2666-7568(24)00048-5. Epub 2024 May 14.

  PMID: 38759667 DERIVED

Related Links

• GORTEC

MeSH Terms

Conditions

Neoplasm Metastasis; Squamous Cell Carcinoma of Head and Neck; Recurrence

Interventions

Fluorouracil; Cetuximab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site; Disease Attributes

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 30, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2020
• Study Completion: May 26, 2020
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

FR (2)