Elderly Independent Patients With Non Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsors and Collaborators:	Groupe Francais De Pneumo-Cancerologie Sanofi-Synthelabo Chugai Pharma USA
Information provided by:	Groupe Francais De Pneumo-Cancerologie
ClinicalTrials.gov Identifier:	NCT00418704

Purpose

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.

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: Erlotinib Drug: taxotere	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Gemcitabine hydrochloride Gemcitabine Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
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.

Further study details as provided by Groupe Francais De Pneumo-Cancerologie:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2009

Intervention Details:

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

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.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418704

Contacts

Contact: Hervé LECAER, Professor

+33 94 60 51 10

herve.lecaer@ch-draguignan.fr

Locations

France
Hospital Draguignan	Recruiting
DRAGUIGNAN, France, 83300
Contact: Hervé LECAER, Professor +33 4 94 60 51 10 herve.lecaer@ch-draguignan.fr
Principal Investigator: Christos CHOUAID, Professor
Hôpital du Cluzeau	Recruiting
LIMOGES, France
Contact: Alain VERGNENEGRE, Professor +33 5 55 05 66 29 avergne@unilim.fr
Principal Investigator: Alain VERGNENEGRE, Professor

Sponsors and Collaborators

Groupe Francais De Pneumo-Cancerologie

Sanofi-Synthelabo

Chugai Pharma USA

Investigators

Principal Investigator:

Hervé LECAER, Professor

Groupe Francais De Pneumo-Cancerologie

More Information

Groupement Francais de Pneumo-cancérologie This link exits the ClinicalTrials.gov site

Responsible Party:	GFPC ( Dr LECAER Hervé )
Study ID Numbers:	GFPC 05-04
Study First Received:	January 4, 2007
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00418704
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Groupe Francais De Pneumo-Cancerologie:

cancer
Lung cancer
None small-cell lung cancer

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Disease Progression
Carcinoma
Carcinoma, Small Cell
Docetaxel

Pleural Effusion
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009