Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma
Information source: Institut Claudius Regaud
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Neoplasms
Intervention: Tarceva (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Institut Claudius Regaud Official(s) and/or principal investigator(s):
Jean Pierre Delord, Docteur, Principal Investigator, Affiliation: Institut Claudius Regaud
Overall contact:
Jean-Pierre Delord, Doctor, Phone: +33 5.61.42.40.79, Email: Delord. Jean-Pierre@claudiusregaud.fr
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.
Clinical Details
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 design: Interventional, Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Jean-Pierre Delord, Doctor, Phone: +33 5.61.42.40.79, Email: Delord. Jean-Pierre@claudiusregaud.fr
Center Oscar Lambret, Lille, France; Recruiting
J. Lefebvre, Pr
Institut claudius regaud, Toulouse, France; Recruiting
Jean Pierre Delord, Doctor, Phone: +33 40.795.59.42., Email: Delord.Jean-Pierre@claudiusregaud.fr
Jérome Sarini, Docteur, Sub-Investigator
Elie Serrano, Professeur, Sub-Investigator
Josiane Percodani, Docteur, Sub-Investigator
Adil Benlyazid, Docteur, Sub-Investigator
Michel Rives, Docteur, Sub-Investigator
Nathalie Caunes, Docteur, Sub-Investigator
Additional Information
Starting date:
October 2003
Ending date: December 2006
Last updated: November 13, 2006
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