Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma

Institut Claudius Regaud

Status: Completed

Conditions: Head and Neck Neoplasms

Treatments: Drug: Tarceva

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00144976

03 VADS 01

Details and patient eligibility

About

The purpose of this study is to evaluate the biological effect of Tarceva (OSI-774) from an inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who are carriers of head and neck epidermoid carcinoma.

Full description

Patients will receive Tarceva in continuous between 18 and 28 days after pan-endoscopy exam until surgery

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.