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

September 2, 2005
May 9, 2008
October 2003
December 2006   (final data collection date for primary 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.
Same as current
Complete list of historical versions of study NCT00144976 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Head and Neck Neoplasms
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
December 2006
December 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00144976
03 VADS 01
Yes
Dr Jean-Pierre DELORD, Institut Claudius Regaud
Institut Claudius Regaud
Hoffmann-La Roche
Principal Investigator: Jean Pierre Delord, Docteur Institut Claudius Regaud
Institut Claudius Regaud
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP