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.

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Drug: Tarceva

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Center Oscar Lambret
  • Toulouse, France
    • Institut Claudius Regaud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud
• Collaborators: Roche Pharma AG
• Investigators: Principal Investigator: Jean Pierre Delord, Docteur, Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: September 2, 2005
• First Submitted That Met QC Criteria: September 2, 2005
• First Posted (Estimate): September 5, 2005

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Tarceva; Head and Neck Neoplasms; ENT
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: 03 VADS 01