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Elderly Dependent Patients With Non Small Cell Lung Cancer (NSCLC)
This study is currently recruiting participants.
Verified by Groupe Francais De Pneumo-Cancerologie, May 2008
Sponsored by: Groupe Francais De Pneumo-Cancerologie
Information provided by: Groupe Francais De Pneumo-Cancerologie
ClinicalTrials.gov Identifier: NCT00419042
  Purpose

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


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: TARCEVA
Drug: Gemzar
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: 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 et IIIB 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.

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

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 100
Study Start Date: July 2006
Estimated Study Completion Date: January 2009
Intervention Details:
    Drug: TARCEVA
    Tarceva (150 mg) is a pill you take once a day -- every day -- to help treat non-small cell lung cancer.
    Drug: Gemzar
    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
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 et IIIB (T4 with pleural effusion) in elderly dependent patients

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • superior vena cava syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419042

Contacts
Contact: Hervé JULLIAN, Doctor +33 4 42 43 23 90 herve.jullian@ch-martigues.fr

Locations
France
Hospital MARTIGUES Recruiting
MARTIGUES, France, 13500
Contact: Hervé JULLIAN, Professor     +33 4 42 43 23 90     herve.ljullian@ch-martigues.fr    
Principal Investigator: Hervé JULLIAN, Doctor            
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
Investigators
Principal Investigator: Hervé JULLIAN, Doctor Groupe Francais De Pneumo-Cancerologie
  More Information

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

Responsible Party: GFPC ( Dr JULLIAN Hervé )
Study ID Numbers: GFPC 05-05
Study First Received: January 4, 2007
Last Updated: June 2, 2008
ClinicalTrials.gov Identifier: NCT00419042  
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
Carcinoma, Small Cell
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Disease Progression
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009