Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma
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|ClinicalTrials.gov Identifier: NCT00144976|
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : March 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Drug: Tarceva||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
- 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.Other Name: erlotinib
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144976
|Center Oscar Lambret|
|Institut claudius regaud|
|Principal Investigator:||Jean Pierre Delord, Docteur||Institut Claudius Regaud|