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

NCT00144976 | Completed DMC

• 1 other identifier: 03 VADS 01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Head and Neck Neoplasms

Keywords

Head and Neck Neoplasms; Tarceva; ENT

Outcome Measures

Primary Outcomes (1)

• 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)

• 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.

Interventions

Tarceva DRUG

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.

Also known as: erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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.

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Roche Pharma AG: collaborator

Study Sites (2)

Center Oscar Lambret

Lille, France

Location

Institut claudius regaud

Toulouse, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean Pierre Delord, Docteur

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: October 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: March 27, 2015

Record last verified: 2008-05

Locations

FR (2)