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

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT00419042
• Lead Sponsor: Groupe Francais De Pneumo-Cancerologie

Brief Summary

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

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

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2006-09
• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Status Verified: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2013-09-29
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (23)

Site 22; 🇫🇷 Beauvais, France

Site 43; 🇫🇷 Caen, France

Site 30; 🇫🇷 Charleville Mezieres, France

Site 04; 🇫🇷 GAP, France

Site 12; 🇫🇷 Aix En Provence, France

Site 07; 🇫🇷 Draguignan, France

Site 41; 🇫🇷 Le Chesnay, France

Site 05; 🇫🇷 Bastia, France

Site 33; 🇫🇷 Creteil, France

Site 01; 🇫🇷 Meaux, France

Site 42; 🇫🇷 Orleans, France

Site 26; 🇫🇷 Paris, France

Site 14; 🇫🇷 Toulon, France

Site 11; 🇫🇷 Villefranche Sur Saone, France

Site 00; 🇫🇷 Limoges, France

Site 27; 🇫🇷 Martigues, France

Site 02; 🇫🇷 Reims, France

Site 19; 🇫🇷 Perigueux, France

Site 25; 🇫🇷 Mantes La Jolie, France

Site 06; 🇫🇷 Marseille, France

Site 32; 🇫🇷 Elbeuf, France

Site 17; 🇫🇷 Rouen, France

Site 20; 🇫🇷 Rennes, France