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

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

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site 12, Aix-en-Provence, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tarceva

Drug

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

Other names: Erlotinib

Gemzar

Drug

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

Other names: Gemcitabine

Sponsors and collaborators

Lead sponsor

Groupe Francais De Pneumo-Cancerologie

Other

Registry information

Official study title

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.

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2010
First posted: Jan 5, 2007
Registry last updated: Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed