Elderly Independent Patients With Non Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00418704
Last Updated: 2013-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2006-05-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Erlotinib
Tarceva (150 mg) is a pill you take once a day -- every day
taxotere
Taxotere® (docetaxel) is given intravenously (I.V.) into the vein. Taxotere® chemotherapy treatment takes about one hour, and usually people receive treatments every three weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Comorbidities score,
* PS frailty score\*\*.according to(TABLE N°1)
* No dementia, repeated falls, faecal or urinary incontinence, ADL=0, IADL=0
* Life expectancy at least 12 weeks
* Créatinine clearance de la créatinine \> or =30cc/mn according to Cockrofts
* Gault formula
* Competency to give written informed consent
* Haematological function as follows: absolute neutrophil count \> 1.5 x 109/l and/or platelet\> 100 x 109/l, hémoglobine \> or = 9,5 g/dl
* Hepatic function as followed :bilirubin \<1,25 LNS SGOT/SGPT \<5 x N,PAL \<5N
* PS \< 3
* No symptomatic cerebral metastasis
* Histologically or cytologically confirmed NSCLC
* Stage IV/IIIB4 (T4with pleural effusion)
* No prior chemotherapy for NSCLC
* Relapses of previous NSCLC treated by surgery or radiotherapy are eligible if the target is measurable out of initial radiotherapy field and if histological or cytological proof
* At least one measurable target lesion by RECIST guidelines.
Exclusion Criteria
* Any severe co-morbidity calculated by Charlson score (according to table 1), any kind of disorder that compromises the ability of the subject to give written informed and/or comply with the study procedure ADL \> or = 1 et IADL \> or =1 Dementia, repeated falls, faecal or urinary incontinence- Peripheral neuropathy grade 2 or more
* Performance Status \> 2 ( ECOG)- Contraindication to corticosteroids
* Unwilling or unable to comply with study requirements for personal , family, sociologic, geographic or any reasons
* Lack of liberty following administrative or judicial decision
* Hypersensitivity to polysorbate
* Hypersensitivity to erlotinib or any excipients of this product
* Unusual hereditary disorders as galactosemia, deficit in lactase and malabsorption in glucose or galactose
* Participation in concomitant clinical trial
* Contraindication to a product of this study disease
* Bronchioloalvéolar or neuroendocrine or composite carcinoma
* Superior vena cava syndrome
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Chugai Pharma USA
INDUSTRY
Groupe Francais De Pneumo-Cancerologie
OTHER
Responsible Party
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Principal Investigators
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Hervé LECAER, Doctor
Role: PRINCIPAL_INVESTIGATOR
Groupe Francais De Pneumo-Cancerologie
Locations
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Site 12
Aix-en-Provence, , France
Site 22
Beauvais, , France
Site 30
Charleville-Mézières, , France
Site 48
Clermont-Ferrand, , France
Site 33
Créteil, , France
Site 07
Draguignan, , France
Site 32
Elbeuf, , France
Site 04
Gap, , France
Site 41
Le Chesnay, , France
Site 00
Limoges, , France
Site 25
Mantes-la-Jolie, , France
Site 06
Marseille, , France
Site 27
Martigues, , France
Site 01
Meaux, , France
Site 26
Paris, , France
Site 19
Périgueux, , France
Site 02
Reims, , France
Site 20
Rennes, , France
Site 18
Rouen, , France
Site 17
Rouen, , France
Site 14
Toulon, , France
Site 11
Villefranche-sur-Saône, , France
Countries
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Related Links
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Groupement Francais de Pneumo-cancérologie
Other Identifiers
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GFPC 05-04
Identifier Type: -
Identifier Source: org_study_id