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

Sponsor
Groupe Francais De Pneumo-Cancerologie (Other)
Overall Status
Completed
CT.gov ID
NCT00418704
Collaborator
Sanofi (Industry), Chugai Pharma USA (Industry)
100
Enrollment
22
Locations
37
Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

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

Study Design

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 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.
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Jun 1, 2006
Actual Study Completion Date :
Jun 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Site 12 Aix En Provence France 13100
    2 Site 22 Beauvais France 60021
    3 Site 30 Charleville Mezieres France 08000
    4 Site 48 Clermont Ferrand France 63000
    5 Site 33 Creteil France 94010
    6 Site 07 Draguignan France 83300
    7 Site 32 Elbeuf France 76503
    8 Site 04 GAP France 05000
    9 Site 41 Le Chesnay France 78157
    10 Site 00 Limoges France
    11 Site 25 Mantes La Jolie France 78200
    12 Site 06 Marseille France 13274
    13 Site 27 Martigues France 13695
    14 Site 01 Meaux France 77108
    15 Site 26 Paris France 75012
    16 Site 19 Perigueux France 24019
    17 Site 02 Reims France 51092
    18 Site 20 Rennes France 35033
    19 Site 18 Rouen France 76031
    20 Site 17 Rouen France 76233
    21 Site 14 Toulon France 83800
    22 Site 11 Villefranche Sur Saone France 69655

    Sponsors and Collaborators

    • Groupe Francais De Pneumo-Cancerologie
    • Sanofi
    • Chugai Pharma USA

    Investigators

    • Principal Investigator: Hervé LECAER, Doctor, Groupe Francais De Pneumo-Cancerologie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Groupe Francais De Pneumo-Cancerologie
    ClinicalTrials.gov Identifier:
    NCT00418704
    Other Study ID Numbers:
    • GFPC 05-04
    First Posted:
    Jan 5, 2007
    Last Update Posted:
    Oct 1, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by Groupe Francais De Pneumo-Cancerologie
    cancer
    Lung cancer
    None small-cell lung cancer
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Docetaxel
    Erlotinib Hydrochloride

    Study Results

    No Results Posted as of Oct 1, 2013