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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.


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Neoplasms

Thank you

Trial Information

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.


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

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.

Principal Investigator

Jean Pierre Delord, Docteur

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

03 VADS 01

NCT ID:

NCT00144976

Start Date:

October 2003

Completion Date:

December 2006

Related Keywords:

  • Head and Neck Neoplasms
  • Head and Neck Neoplasms
  • Tarceva
  • ENT
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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