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

NCT ID: NCT00144976

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2006-12-31

Brief 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.

Detailed Description

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

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

erlotinib

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Institut Claudius Regaud

Principal Investigators

Jean Pierre Delord, Docteur

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud

Locations

Center Oscar Lambret

Lille, , France

Institut claudius regaud

Toulouse, , France

Countries

France

Other Identifiers

03 VADS 01

Identifier Type: -

Identifier Source: org_study_id