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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Claudius Regaud
• Collaborator: Roche Pharma AG
• Treatments: Erlotinib Hydrochloride

Criteria

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.