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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00419042
Recruitment Status : Completed
First Posted : January 5, 2007
Last Update Posted : October 1, 2013
Information provided by (Responsible Party):
Groupe Francais De Pneumo-Cancerologie

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

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Drug: TARCEVA Drug: Gemzar

Detailed Description:
A multicenter phase II trial,prospective,randomized,open,non comparative

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: 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.
Study Start Date : July 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

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.
    Other Name: Erlotinib
    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
    Other Name: Gemcitabine

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00419042

Site 12
Aix En Provence, France, 13100
Site 05
Bastia, France, 20200
Site 22
Beauvais, France, 60021
Site 43
Caen, France, 14000
Site 30
Charleville Mezieres, France, 08000
Site 33
Creteil, France, 94010
Site 07
Draguignan, France, 83300
Site 32
Elbeuf, France, 76503
Site 04
GAP, France, 05000
Site 41
Le Chesnay, France, 78157
Site 00
Limoges, France
Site 25
Mantes La Jolie, France, 78200
Site 06
Marseille, France, 13274
Site 27
Martigues, France, 13695
Site 01
Meaux, France, 77108
Site 42
Orleans, France, 45032
Site 26
Paris, France, 75012
Site 19
Perigueux, France, 24019
Site 02
Reims, France, 51092
Site 20
Rennes, France, 35033
Site 17
Rouen, France, 76233
Site 14
Toulon, France, 83800
Site 11
Villefranche Sur Saone, France, 69655
Sponsors and Collaborators
Groupe Francais De Pneumo-Cancerologie
Principal Investigator: Hervé LECAER, Doctor Groupe Francais De Pneumo-Cancerologie

Additional Information:
Responsible Party: Groupe Francais De Pneumo-Cancerologie Identifier: NCT00419042     History of Changes
Other Study ID Numbers: GFPC 05-05
First Posted: January 5, 2007    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: March 2010

Keywords provided by Groupe Francais De Pneumo-Cancerologie:
Lung cancer
None small-cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors