Clinical trial NCT00418704: Elderly Independent Patients With Non Small Cell Lung Cancer (NSCLC)
Official title: A Multicenter Randomized Phase II Trial in NSCLC Stage IV and IIIB (T4 With Pleural Effusion) in Elderly Independent Patients the Schedule Docetaxel / Gemcitabine First Line Following by Erlotinib When Progression Versus Erlotinib First Line Following 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
Collaborators: name: Sanofi
name: Chugai Pharma USA
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 and IIIB (T4 with pleural effusion) in elderly independent patients évaluant

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

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: Site 12
city: Beauvais
country: France
facility: Site 22
city: Charleville Mezieres
country: France
facility: Site 30
city: Clermont Ferrand
country: France
facility: Site 48
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: 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 18
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: