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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144976
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : March 27, 2015
Roche Pharma AG
Information provided by:
Institut Claudius Regaud

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Tarceva Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Correlation study between pharmacokinetic and biological effect observed of molecule OSI-774.
  2. 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.
  3. Characterisation of OSI-774 modes of action from the cellular cycle arrest proteinic effectors's point of view.
  4. 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.
  5. Pharmacogenomics study of Tarceva's metabolism : genes studied code for cytochrome 3A5 and glycoprotein-P.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144976

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Center Oscar Lambret
Lille, France
Institut claudius regaud
Toulouse, France
Sponsors and Collaborators
Institut Claudius Regaud
Roche Pharma AG
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Principal Investigator: Jean Pierre Delord, Docteur Institut Claudius Regaud

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Responsible Party: Dr Jean-Pierre DELORD, Institut Claudius Regaud Identifier: NCT00144976     History of Changes
Other Study ID Numbers: 03 VADS 01
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: May 2008
Keywords provided by Institut Claudius Regaud:
Head and Neck Neoplasms
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Squamous Cell
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action