Clinical trial NCT01864772: Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic or Recurrent Head and Neck Squamous Cell Cancer
Keywords: HNSCC
Metastatic
Recurrent
Elderly
Geriatry
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
Collaborators: name: Gustave Roussy, Cancer Campus, Grand Paris
First posted: 2013-05-30
Enrollment: 85
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Objective response and acute toxicity
timeFrame: 1 month after the end of chemotherapy
Secondary outcomes:
measure: Best objective tumor response
timeFrame: 6 weeks after the end of treatment
measure: Overall survival
timeFrame: 1 year after the end of treatment
measure: progression free survival
timeFrame: 1 year after the end of treatment
measure: Duration of response under cetuximab maintenance therapy
timeFrame: 1 year after the end of maintenance
measure: Toxicity of cetuximab maintenance therapy
timeFrame: 3 months after the end of maintenance
measure: autonomy
timeFrame: 1 month after the end of treatment
measure: Health related quality of life
timeFrame: 1 month after the end of chemotherapy
Other outcomes:
Locations:
city: Draguignan
country: France
facility: Hôpital de la Dracénie
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: