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

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT00418704
• Lead Sponsor: Groupe Francais De Pneumo-Cancerologie

Brief Summary

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

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

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2006-06
• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Study Completion: 2009-06
• Status Verified: 2013-09
• 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 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (22)

Site 12; 🇫🇷 Aix En Provence, France

Site 22; 🇫🇷 Beauvais, France

Site 30; 🇫🇷 Charleville Mezieres, France

Site 00; 🇫🇷 Limoges, France

Site 48; 🇫🇷 Clermont Ferrand, France

Site 32; 🇫🇷 Elbeuf, France

Site 04; 🇫🇷 GAP, France

Site 26; 🇫🇷 Paris, France

Site 41; 🇫🇷 Le Chesnay, France

Site 25; 🇫🇷 Mantes La Jolie, France

Site 06; 🇫🇷 Marseille, France

Site 27; 🇫🇷 Martigues, France

Site 01; 🇫🇷 Meaux, France

Site 19; 🇫🇷 Perigueux, 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 Saone, France

Site 33; 🇫🇷 Creteil, France

Site 07; 🇫🇷 Draguignan, France