Clinical trial NCT00419042: Elderly Dependent Patients With Non Small Cell Lung Cancer (NSCLC)
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: cancer
Lung cancer
None small-cell lung cancer
Lead sponsor: Groupe Francais De Pneumo-Cancerologie
Sponsor class: OTHER
First posted: 2007-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients

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

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: Site 12
city: Bastia
country: France
facility: Site 05
city: Beauvais
country: France
facility: Site 22
city: Caen
country: France
facility: Site 43
city: Charleville Mezieres
country: France
facility: Site 30
city: Creteil
country: France
facility: Site 33
city: Draguignan
country: France
facility: Site 07
city: Elbeuf
country: France
facility: Site 32
city: GAP
country: France
facility: Site 04
city: Le Chesnay
country: France
facility: Site 41
city: Limoges
country: France
facility: Site 00
city: Mantes La Jolie
country: France
facility: Site 25
city: Marseille
country: France
facility: Site 06
city: Martigues
country: France
facility: Site 27
city: Meaux
country: France
facility: Site 01
city: Orleans
country: France
facility: Site 42
city: Paris
country: France
facility: Site 26
city: Perigueux
country: France
facility: Site 19
city: Reims
country: France
facility: Site 02
city: Rennes
country: France
facility: Site 20
city: Rouen
country: France
facility: Site 17
city: Toulon
country: France
facility: Site 14
city: Villefranche Sur Saone
country: France
facility: Site 11
Study officials:
affiliation: Groupe Francais De Pneumo-Cancerologie
name: Hervé LECAER, Doctor
role: PRINCIPAL_INVESTIGATOR
References: