Clinical trial · Interventional
Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma
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.
NCT00144976CI-TRIAL-00017289completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tarceva | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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 outcomes (5)
- measure
- Correlation study between pharmacokinetic and biological effect observed of molecule OSI-774.
- measure
- 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.
- measure
- Characterisation of OSI-774 modes of action from the cellular cycle arrest proteinic effectors's point of view.
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTThomas F, Rochaix P, Benlyazid A, Sarini J, Rives M, Lefebvre JL, Allal BC, Courbon F, Chatelut E, Delord JP. Pilot study of neoadjuvant treatment with erlotinib in nonmetastatic head and neck squamous cell carcinoma. Clin Cancer Res. 2007 Dec 1;13(23):7086-92. doi: 10.1158/1078-0432.CCR-07-1370. PMID 18056187
- RESULTThomas F, Rochaix P, White-Koning M, Hennebelle I, Sarini J, Benlyazid A, Malard L, Lefebvre JL, Chatelut E, Delord JP. Population pharmacokinetics of erlotinib and its pharmacokinetic/pharmacodynamic relationships in head and neck squamous cell carcinoma. Eur J Cancer. 2009 Sep;45(13):2316-23. doi: 10.1016/j.ejca.2009.05.007. Epub 2009 Jun 10. PMID 19523815
- RESULTThomas F, Delmar P, Vergez S, Rochaix P, Hennebelle I, McLoughlin P, Benlyazid A, Sarini J, Delord JP. Gene expression profiling on pre- and post-erlotinib tumors from patients with head and neck squamous cell carcinoma. Head Neck. 2013 Jun;35(6):809-18. doi: 10.1002/hed.23036. Epub 2012 Jul 13. PMID 22791662