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

NCT ID: NCT01864772

Last Updated: 2022-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2020-05-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carbo, 5FU, Cetuximab

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

Group Type: EXPERIMENTAL

Carbo, 5FU, Cetuximab

Intervention Type: 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

Interventions

Carbo, 5FU, Cetuximab

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• Presence of medical or physiological factors susceptible to modify patient compliance with study protocol and follow-up or Informed Consent Form signing.
• Known allergy or hypersensibility to monoclonal antibodies (bevacizumab, cetuximab), or to other chemotherapies of the study or to their excipients

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

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: collaborator

Groupe Oncologie Radiotherapie Tete et Cou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital de la Dracénie

Draguignan, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 38759667 (View on PubMed)

Related Links

http://www.gortec.fr/

GORTEC

Other Identifiers

GORTEC ELAN-FIT

Identifier Type: -

Identifier Source: org_study_id