Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma

Head and Neck Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144976
• Other study ID #: 03 VADS 01
• Status: Completed
• Phase: N/A
• First received: September 2, 2005
• Last updated: March 26, 2015
• Start date: October 2003
• Est. completion date: December 2006

Study information

• Verified date: May 2008
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 head and neck epidermoid carcinoma.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Center Oscar Lambret	Lille
France	Institut claudius regaud	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Institut Claudius Regaud	Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation study between pharmacokinetic and biological effect observed of molecule OSI-774.
Secondary	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.
Secondary	Characterisation of OSI-774 modes of action from the cellular cycle arrest proteinic effectors's point of view.
Secondary	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.
Secondary	Pharmacogenomics study of Tarceva's metabolism : genes studied code for cytochrome 3A5 and glycoprotein-P.