Elderly Independent Patients With Non Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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The purpose of this study is to determine duration before progression of first-line treatment chemotherapy following erlotinib in second-line comparing erlotinib in first-line following chemotherapy in second-line in old patients with none small cell lung cancer.

Detailed Description
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A multicenter phase II trial , prospective, randomized, open, non comparative

Official Title
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A Multicenter Randomized Phase II Trial in NSCLC Stage IV and IIIB (T4 With Pleural Effusion) in Elderly Independent Patients the Schedule Docetaxel / Gemcitabine First Line Following by Erlotinib When Progression Versus Erlotinib First Line Following by/ Gemcitabine When Progression.

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Erlotinib
* Drug: taxotere


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 65 years 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: Symptomatic cerebral metastasis 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Erlotinib|Tarceva (150 mg) is a pill you take once a day -- every day|
|Drug: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, Lung cancer, None small-cell lung cancer