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

NCT00419042 | Completed DMC

• 1 other identifier: GFPC 05-05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 23

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

Conditions

Non Small Cell Lung Cancer

Keywords

cancer; Lung cancer; None small-cell lung cancer

Interventions

TARCEVA DRUG

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

Also known as: 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

Also known as: Gemcitabine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Francais De Pneumo-Cancerologie: lead

Study Sites (23)

Site 12

Aix-en-Provence, 13100, France

Location

Site 05

Bastia, 20200, France

Location

Site 22

Beauvais, 60021, France

Location

Site 43

Caen, 14000, France

Location

Site 30

Charleville-Mézières, 08000, France

Location

Site 33

Créteil, 94010, France

Location

Site 07

Draguignan, 83300, France

Location

Site 32

Elbeuf, 76503, France

Location

Site 04

Gap, 05000, France

Location

Site 41

Le Chesnay, 78157, France

Location

Site 00

Limoges, France

Location

Site 25

Mantes-la-Jolie, 78200, France

Location

Site 06

Marseille, 13274, France

Location

Site 27

Martigues, 13695, France

Location

Site 01

Meaux, 77108, France

Location

Site 42

Orléans, 45032, France

Location

Site 26

Paris, 75012, France

Location

Site 19

Périgueux, 24019, France

Location

Site 02

Reims, 51092, France

Location

Site 20

Rennes, 35033, France

Location

Site 17

Rouen, 76233, France

Location

Site 14

Toulon, 83800, France

Location

Site 11

Villefranche-sur-Saône, 69655, France

Location

Related Links

• Groupement Francais de Pneumo-cancérologie

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Lung Neoplasms

Interventions

Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Hervé LECAER, Doctor

  Groupe Francais De Pneumo-Cancerologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2007
• First Posted: January 5, 2007
• Study Start: July 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: March 1, 2010
• Last Updated: October 1, 2013

Record last verified: 2010-03

Locations

FR (23)