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

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ClinicalTrials.gov Identifier: NCT01864772
Recruitment Status : Recruiting
First Posted : May 30, 2013
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou

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).

Condition or disease Intervention/treatment Phase
Metastatic or Recurrent Head and Neck Squamous Cell Cancer Drug: Carbo, 5FU, Cetuximab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  1. Objective response and acute toxicity [ Time Frame: 1 month after the end of chemotherapy ]
    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


Secondary Outcome Measures :
  1. Best objective tumor response [ Time Frame: 6 weeks after the end of treatment ]
    Best objective tumor response during treatment

  2. Overall survival [ Time Frame: 1 year after the end of treatment ]
    Overall survival

  3. progression free survival [ Time Frame: 1 year after the end of treatment ]
    progression free survival

  4. Duration of response under cetuximab maintenance therapy [ Time Frame: 1 year after the end of maintenance ]
    Duration of response under cetuximab maintenance therapy

  5. Toxicity of cetuximab maintenance therapy [ Time Frame: 3 months after the end of maintenance ]
    Toxicity of cetuximab maintenance therapy

  6. autonomy [ Time Frame: 1 month after the end of treatment ]
    Autonomy assessed by ADL and IADL scales during treatment and until 1 month after the end of treatment

  7. Health related quality of life [ Time Frame: 1 month after the end of chemotherapy ]
    Quality of life assessed by EORTC QLQ-C30 and QLQ-HN35 questionnaires



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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:

  • 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

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): NCT01864772


Contacts
Contact: Herve LE CAER, MD herve.lecaer@ch-draguignan.fr
Contact: Nadejda VINTONENKO, PhD gortec@orange.fr

Locations
France
Hôpital de la Dracénie Not yet recruiting
Draguignan, France, 83300
Contact: Herve LE CAER, MD       herve.lecaer@ch-draguignan.fr   
Principal Investigator: Herve LE CAER, MD         
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Joel GUIGAY, MD, PhD       joel.guigay@igr.fr   
Principal Investigator: Joel GUIGAY, MD,PhD         
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
Gustave Roussy, Cancer Campus, Grand Paris

Additional Information:
GORTEC  This link exits the ClinicalTrials.gov site

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT01864772     History of Changes
Other Study ID Numbers: GORTEC ELAN-FIT
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: February 2018

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
HNSCC
Metastatic
Recurrent
Elderly
Geriatry

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma
Carboplatin
Cetuximab
Antineoplastic Agents