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

Non Small Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418704
• Other study ID #: GFPC 05-04
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2007
• Last updated: September 29, 2013
• Start date: May 2006
• Est. completion date: June 2009

Study information

• Verified date: September 2013
• Source: Groupe Francais De Pneumo-Cancerologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2009
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Erlotinib
Tarceva (150 mg) is a pill you take once a day -- every day
• taxotere
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.

Locations

Country	Name	City	State
France	Site 12	Aix En Provence
France	Site 22	Beauvais
France	Site 30	Charleville Mezieres
France	Site 48	Clermont Ferrand
France	Site 33	Creteil
France	Site 07	Draguignan
France	Site 32	Elbeuf
France	Site 04	GAP
France	Site 41	Le Chesnay
France	Site 00	Limoges
France	Site 25	Mantes La Jolie
France	Site 06	Marseille
France	Site 27	Martigues
France	Site 01	Meaux
France	Site 26	Paris
France	Site 19	Perigueux
France	Site 02	Reims
France	Site 20	Rennes
France	Site 17	Rouen
France	Site 18	Rouen
France	Site 14	Toulon
France	Site 11	Villefranche Sur Saone

Sponsors (3)

Lead Sponsor	Collaborator
Groupe Francais De Pneumo-Cancerologie	Chugai Pharma USA, Sanofi

Country where clinical trial is conducted

France, 

External Links

•   Groupement Francais de Pneumo-cancérologie