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

Groupe Francais De Pneumo-Cancerologie

Status: Completed

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: TARCEVA; Drug: Gemzar

Study type: Observational

Funder types: Other

Identifiers

NCT00419042

GFPC 05-05

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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