| 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 |
| |
| 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 |
| Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| Head and Neck Neoplasms |
| Drug: Tarceva |
| |
| |
| |
| 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 |
| Dr Jean-Pierre DELORD, Institut Claudius Regaud |
| 03 VADS 01 |
| Institut Claudius Regaud |
| Hoffmann-La Roche |
| Principal Investigator: |
Jean Pierre Delord, Docteur |
Institut Claudius Regaud |
|
|
| Institut Claudius Regaud |
| May 2008 |