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

NCT00418704 | Completed

• 1 other identifier: GFPC 05-04
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 22

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.

Conditions

Non Small Cell Lung Cancer

Keywords

cancer; Lung cancer; None small-cell lung cancer

Interventions

Erlotinib DRUG

Tarceva (150 mg) is a pill you take once a day -- every day

taxotere DRUG

Taxotere® (docetaxel) is given intravenously (I.V.) into the vein. Taxotere® chemotherapy treatment takes about one hour, and usually people receive treatments every three weeks.

Also known as: Docetaxel

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 and IIIB (T4 with pleural effusion) in elderly independent patients évaluant

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Francais De Pneumo-Cancerologie: lead
• Sanofi: collaborator
• Chugai Pharma USA: collaborator

Study Sites (22)

Site 12

Aix-en-Provence, 13100, France

Location

Site 22

Beauvais, 60021, France

Location

Site 30

Charleville-Mézières, 08000, France

Location

Site 48

Clermont-Ferrand, 63000, 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 26

Paris, 75012, France

Location

Site 19

Périgueux, 24019, France

Location

Site 02

Reims, 51092, France

Location

Site 20

Rennes, 35033, France

Location

Site 18

Rouen, 76031, 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; Docetaxel

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

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: May 1, 2006
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2009
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

FR (22)