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| Sponsor: | Institut Claudius Regaud |
|---|---|
| Collaborator: |
Hoffmann-La Roche |
| Information provided by: | Institut Claudius Regaud |
| ClinicalTrials.gov Identifier: | NCT00144976 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Head and Neck Neoplasms |
Drug: Tarceva |
| Study Type: | Interventional |
| Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| 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. |
| Enrollment: | 43 |
| Study Start Date: | October 2003 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Patients will receive Tarceva in continuous between 18 and 28 days after pan-endoscopy exam until surgery
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| Institut claudius regaud | |
| Toulouse, France | |
| Center Oscar Lambret | |
| Lille, France | |
| Principal Investigator: | Jean Pierre Delord, Docteur | Institut Claudius Regaud |
More Information
| Responsible Party: | Institut Claudius Regaud ( Dr Jean-Pierre DELORD ) |
| Study ID Numbers: | 03 VADS 01 |
| Study First Received: | September 2, 2005 |
| Last Updated: | May 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00144976 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Head and Neck Neoplasms Tarceva ENT |
|
Erlotinib Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Head and Neck Neoplasms Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |