Pilot Study, Without Direct Individual Benefice, of Biological Effect of Tarceva (OSI-774) at Posology of 150 mg by Day for Patients Stricken by ENT Epidermoid Carcinoma Waiting for First Surgical Picking up.
Inclusion Criteria:
- Neck and head epidermoid carcinoma histologically proved. Patient with an ENT
epidermoid tumor can be included in the study if this relapse is located in an area
not irradiated yet.
- At least tumor classified T2NXM0
- Patient who can be picked up in a first surgery with a curative purpose or who must
have a necessity's surgery (cervical curettage for voluminous adenopathies before
radiotherapy)
- Patient without clinical or radiological sign of metastatic disease
- Good general status (OMS ≤ 2)
- Patient able to ingest food.
- Age ≥ 18 years
- Well-informed written consent, signed by the patient.
- Patient with sickness benefit
Exclusion Criteria:
- Patient with relapse ever treated by radiotherapy
- Other prospective study's participation
- Recent and massive digestive haemorrhage
- Medical contra-indication like main general status alteration, uncontrolled serious
infectious disease, main uncontrolled metabolic anomaly ongoing.
- Pre-existent pulmonary pathology (BPCO, pleurisy, lymphangitis, interstitial
syndrome)
- Severe cardiac pathology (stage 3 or 4 cardiac insufficiency, unstable angina
pectoris, uncontrolled arrhythmia, myocardium's infarction antecedent during the year
that precede the inclusion.
- Ophthalmic pathology antecedent concerning the ocular surface or lens-carrier
- Concomitant administration, by local or general tract, of drug responsible for ocular
drought or which could delay the epithelial cicatrization
- Less than 1000 polynuclear neutrophil leucocytes or less than 75000 blood-platelets
at inclusion
- Bilirubin at higher concentration than one point five times the normal
- Renal insufficiency (glomerular filtration flow ≤ 40 ml/min)calculated in accordance
with Cockroft's formula
- Tacking of Beta blockers, amiodarone, NSAIDs, bleomycin, just before or during the
study
- Pregnant or nursing women
- Patient under guardianship or trusteeship.