Head and Neck NeoplasmsNCT00144976
Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma
A study testing Tarceva in people with Head and Neck Neoplasms, run by Institut Claudius Regaud at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Tarceva
- How many people
- 43 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2003to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Age ≥ 18 years
- Well-informed written consent, signed by the patient.
- Patient with sickness benefit
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
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.
Read the detailed description
Patients will receive Tarceva in continuous between 18 and 28 days after pan-endoscopy exam until surgery
- Conditions
- Head and Neck Neoplasms
- Being tested
- Tarceva
- Keywords
- Head and Neck Neoplasms, Tarceva, ENT
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarcevaDrug
Also called erlotinib
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (5)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Jean Pierre Delord, Docteur, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144976
- Sponsor's protocol ID
- 03 VADS 01
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2005
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thomas F, Rochaix P, Benlyazid A, Sarini J, Rives M, Lefebvre JL, Allal BC, Courbon F, Chatelut E, Delord JP. Pilot study of neoadjuvant treatment with erlotinib in nonmetastatic head and neck squamous cell carcinoma. Clin Cancer Res. 2007 Dec 1;13(23):7086-92. doi: 10.1158/1078-0432.CCR-07-1370.
PubMed 18056187Thomas F, Rochaix P, White-Koning M, Hennebelle I, Sarini J, Benlyazid A, Malard L, Lefebvre JL, Chatelut E, Delord JP. Population pharmacokinetics of erlotinib and its pharmacokinetic/pharmacodynamic relationships in head and neck squamous cell carcinoma. Eur J Cancer. 2009 Sep;45(13):2316-23. doi: 10.1016/j.ejca.2009.05.007. Epub 2009 Jun 10.
PubMed 19523815Thomas F, Delmar P, Vergez S, Rochaix P, Hennebelle I, McLoughlin P, Benlyazid A, Sarini J, Delord JP. Gene expression profiling on pre- and post-erlotinib tumors from patients with head and neck squamous cell carcinoma. Head Neck. 2013 Jun;35(6):809-18. doi: 10.1002/hed.23036. Epub 2012 Jul 13.
PubMed 22791662
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00144976
- Acronym / sponsor ID
- 03 VADS 01
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and Neck Neoplasms, Tarceva, ENT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Oct 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will receive Tarceva in continuous between 18 and 28 days after pan-endoscopy exam until surgery
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TarcevaAlso: erlotinibTarceva 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. | Drug | – |
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.
5 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Results publication: PubMed 18056187Thomas F, Rochaix P, Benlyazid A, Sarini J, Rives M, Lefebvre JL, Allal BC, Courbon F, Chatelut E, Delord JP. Pilot study of neoadjuvant treatment with erlotinib in nonmetastatic head and neck squamous cell carcinoma. Clin Cancer Res. 2007 Dec 1;13(23):7086-92. doi: 10.1158/1078-0432.CCR-07-1370.
- Results publication: PubMed 19523815Thomas F, Rochaix P, White-Koning M, Hennebelle I, Sarini J, Benlyazid A, Malard L, Lefebvre JL, Chatelut E, Delord JP. Population pharmacokinetics of erlotinib and its pharmacokinetic/pharmacodynamic relationships in head and neck squamous cell carcinoma. Eur J Cancer. 2009 Sep;45(13):2316-23. doi: 10.1016/j.ejca.2009.05.007. Epub 2009 Jun 10.
- Results publication: PubMed 22791662Thomas F, Delmar P, Vergez S, Rochaix P, Hennebelle I, McLoughlin P, Benlyazid A, Sarini J, Delord JP. Gene expression profiling on pre- and post-erlotinib tumors from patients with head and neck squamous cell carcinoma. Head Neck. 2013 Jun;35(6):809-18. doi: 10.1002/hed.23036. Epub 2012 Jul 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Pierre Delord, Docteur principal investigator
Institut Claudius Regaud
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tarceva in people with Head and Neck Neoplasms, run by Institut Claudius Regaud at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144976, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.