Elderly Dependent 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 in non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first line followed by Erlotinib when progression versus Erlotinib first line followed by Gemcitabine when progression

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 et IIIB in Elderly Dependent Patients With Evaluation of the Sequence Gemcitabine First Line Followed by Erlotinib When Progression Versus Erlotinib First Line Followed by Gemcitabine When Progression.

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: TARCEVA
* Drug: Gemzar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 65 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: symptomatic cerebral metastasis 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

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: TARCEVA|Tarceva (150 mg) is a pill you take once a day -- every day -- to help treat non-small cell lung cancer.|
|Drug: 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|

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