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

Study Overview
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Brief Summary
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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.

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

Official Title
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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.

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Drug: Tarceva


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tarceva|Tarceva will be administered at dosage 150 mg od one hour before or two hours after meat. Patients will receive Tarceva between 18 and 28 days.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation study between pharmacokinetic and biological effect observed of molecule OSI-774. |  |  | 
| Verification of biological effect of Tarceva's homogeneity (inhibition of EGFR-TK) according to sites, particularly from the point of view of a possible difference primary tumor/metastatic adenopathy and tumorous tissue/healthy tissue. |  |  | 
| Characterisation of OSI-774 modes of action from the cellular cycle arrest proteinic effectors's point of view. |  |  | 
| Constitution of frozen tissue bank for genomic (sequencing) study of tumorous EGF-R structure and for modification of in situ gene expression induction with OSI-774 by RNA microarrays technology. |  |  | 
| Pharmacogenomics study of Tarceva's metabolism : genes studied code for cytochrome 3A5 and glycoprotein-P. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Neoplasms, Tarceva, ENT