Study of Biological Effect of Tarceva (OSI-774) for Patie... | NCT00144976

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

NCT00144976

Sponsor

Institut Claudius Regaud

Status

Completed

Last Update Posted

Mar 27, 2015Estimated

Enrollment

43Actual

Phase

Not Applicable

Conditions

Head and Neck Neoplasms

Interventions

Tarceva

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Sep 2, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2015

Last Update Posted Date

Mar 27, 2015Estimated

Name	Class
Roche Pharma AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Name	Type	Description	Arm Group Labels	Other Names
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.		erlotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Center Oscar Lambret		Lille			France
Institut claudius regaud

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds