Randomized, controlled trial of Platinum-Cetuximab combined either withDocetaxel (TPEx) or with 5FU (Extreme) in patients withrecurrent/metastatic squamous cell cancer of the head and neck

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 416

Inclusion Criteria

Patients:
? Histologically confirmed diagnosis squamous cell carcinoma of head
and neck: oral cavity, oropharynx, hypopharynx, larynx (histological
confirmation is mandatory at least for initial diagnosis).
? Recurrence and/or metastatic disease not suitable for local therapy.
? At least one measurable lesion (RECIST) by CT or MRI.
? PS < 2
? Age < 71 years
? Clearance of creatinine > 60ml/mn (MDRD).
? Haematological function as follows: absolute neutrophil count > 1.5 x
109/l, platelet > 100 x 109/l, hemoglobin >= 9.5 g/dl
? Hepatic function as followed: bilirubin <= Upper Limit of Normal
(ULN); SGOT/SGPT < 1.5 ULN; PAL < 2.5 ULN
? Life expectancy > 12 weeks.
? Consent form signed
? Affiliation to an health insurance
? Negative pregnancy test in women of childbearing potential within 14
days prior to treatment initiation (premenopausal or less than 12
months of amenorrhea post-menopause, and who have not undergone
surgical sterilization). Both men and women (of childbearing potential)
who are sexually active must use adequate contraception, during and for at least 6 months post-treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 416
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Patients with nasopharyngeal cancer, paranasal sinus cancer or
unknown primary.
? Prior systemic chemotherapy for the head and neck carcinoma,
except if given as part of a multimodal treatment for locally advanced
disease which was completed more than 6 months prior to study entry.
? Surgery (excluding diagnostic biopsy) or radiotherapy within 6 weeks
before study entry.
? Contra-indication to receive cisplatin.
? Prior dose of cisplatin > 300 mg/m² (a patient who received prior
RT + 3 cycles of cisplatin or 3 cycles induction TPF, i.e. total dose of
cisplatin ? 300 mg/m², for locally advanced primary HN cancer can be
included)
? Prior anti-EGFR treatment received less than 12 months before
enrolment in the trial
? Known hypersensitivity reaction to any study medication
? Documented or symptomatic brain or leptomeningeal metastasis
? Clinically significant cardiovascular disease, e.g. cardiac failure of
New York Heart Association classes III-IV, uncontrolled coronary artery
disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled
hypertension, or history of myocardial infarction in
the last 12 months
? Active infection (infection requiring IV antibiotics), including active
tuberculosis and known and declared human immunodeficiency virus
(HIV).
? Significant disease which, in the judgment of the investigator, would
make the patient inappropriate for entry into the trial.
? Any social, personal, medical and/or psychologic factor(s) that could
interfere with the observance of the patient to the protocol and/or the
follow-up and/or the signature of the inform consent.
? Pregnant or breast feeding women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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