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

Phase II Multicenter Trial Evaluating First Line Carboplatin, 5-Fluorouracil and Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer, Aged 70 and Over, Ranked as Fit (no Frailty) by Geriatric Assessment

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).

Study Overview

• Status: Completed
• Conditions: Metastatic or Recurrent Head and Neck Squamous Cell Cancer
• Intervention / Treatment: Drug: Carbo, 5FU, Cetuximab

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Draguignan, France, 83300
    • Hôpital de la Dracénie
  • Villejuif, France, 94805
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best objective tumor response	Best objective tumor response during treatment	6 weeks after the end of treatment
Overall survival	Overall survival	1 year after the end of treatment
progression free survival	progression free survival	1 year after the end of treatment
Duration of response under cetuximab maintenance therapy	Duration of response under cetuximab maintenance therapy	1 year after the end of maintenance
Toxicity of cetuximab maintenance therapy	Toxicity of cetuximab maintenance therapy	3 months after the end of maintenance
autonomy	Autonomy assessed by ADL and IADL scales during treatment and until 1 month after the end of treatment	1 month after the end of treatment
Health related quality of life	Quality of life assessed by EORTC QLQ-C30 and QLQ-HN35 questionnaires	1 month after the end of chemotherapy

Collaborators and Investigators

• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Collaborators: Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

Helpful Links

• GORTEC

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2013
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): May 26, 2020

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 24, 2013
• First Posted (ESTIMATE): May 30, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Elderly; Metastatic; HNSCC; Recurrent; Geriatry
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Recurrence; Frailty; Carcinoma, Squamous Cell; Neoplasms, Squamous Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: GORTEC ELAN-FIT