Elderly Dependent Patients With Non Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00419042
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
2006-07-31
2010-03-31
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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TARCEVA
Tarceva (150 mg) is a pill you take once a day -- every day -- to help treat non-small cell lung cancer.
Gemzar
GEMZAR by mixing it into a solution and giving it through a needle into a vein-called intravenous infusion (IV). This will take about 30 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Comorbidities score, PS and frailty score according to table 1
* No dementia, faecal or urinary incontinence, repeated falls
* ADL = 0, IADL = 0-1
* Life expectancy at least 12 weeks
* Creatinin clearance \> = 30 ml/mn (according to Cockcrofts-Gault formula)
* Competency to give written informed consent
* Haematological functions as follows : neutrophiles count \> 1.5 x 109/l and platelets \> 100 x 109/l hemoglobin \> 9,5 g/dl - Hepatic function as follows : Bilirubin \< 1,25 LNS ASAT / ALAT \<5 x NAlcPh \<5 x N
* PS \< 3
* cerebral metastasis eligible if asymptomatic
* Histologically or cytologically confirmed NSCLC
* Stage IV/IIIB4 (T4 with pleural effusion)
* No prior chemotherapy
* relapses of previous NSCLC treated by surgery or radiotherapy are eligible, if the target is measurable out of initial radiotherapy field and if cytological or histological proof
* At least one measurable target lesion by RECIST guidelines
Exclusion Criteria
* Any severe comorbidity calculated by Charlson score according to table 1
* ADL \> 0 and IADL \> 1- performance status \>2 (ECOG)
* peripheral neuropathy grade 2 or more
* dementia, repeated falls, urinary or faecal incontinence
* contra-indication to corticosteroids
* contra indication to a product of this study
* unwilling or unable to comply with study requirements, for personal, family, sociologic, geographic or any other reason
* inability of the subject to give written informed consent
* lack of liberty following legal or administrative decision
* hypersensitivity to polysorbate
* hypersensitivity to erlotinib or any excipients of this product
* unusual hereditary disorders, as galactosemia, deficit in lactase and syndrome of malabsorption in glucose or galactose
* participation in concomitant clinical trial
* bronchioloalveolar or neuroendocrine or composite carcinoma
* superior vena cava syndrome
65 Years
ALL
No
Sponsors
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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 05
Bastia, , France
Site 22
Beauvais, , France
Site 43
Caen, , France
Site 30
Charleville-Mézières, , 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 42
Orléans, , France
Site 26
Paris, , France
Site 19
Périgueux, , France
Site 02
Reims, , France
Site 20
Rennes, , 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 05-05
Identifier Type: -
Identifier Source: org_study_id