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Completed

NCT Number: NCT00144976

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center Oscar Lambret, Lille, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: erlotinib

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

  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.

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 5, 2005
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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