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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00144976
First received: September 2, 2005
Last updated: May 9, 2008
Last verified: May 2008
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • 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:
  • 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.

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)
Intervention Details:
    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
Detailed Description:

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
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144976

Locations
France
Center Oscar Lambret
Lille, France
Institut claudius regaud
Toulouse, France
Sponsors and Collaborators
Institut Claudius Regaud
Hoffmann-La Roche
Investigators
Principal Investigator: Jean Pierre Delord, Docteur Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Dr Jean-Pierre DELORD, Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00144976     History of Changes
Other Study ID Numbers: 03 VADS 01
Study First Received: September 2, 2005
Last Updated: May 9, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
Head and Neck Neoplasms
Tarceva
ENT

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
 Neoplasms by Site
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013