Status:
COMPLETED
Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma
Lead Sponsor:
Institut Claudius Regaud
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
Patients will receive Tarceva in continuous between 18 and 28 days after pan-endoscopy exam until surgery
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00144976
Start Date
October 1 2003
End Date
December 1 2006
Last Update
March 27 2015
Active Locations (2)
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1
Center Oscar Lambret
Lille, France
2
Institut claudius regaud
Toulouse, France