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

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Chugai Pharma USA
Information provided by (Responsible Party):
Groupe Francais De Pneumo-Cancerologie
ClinicalTrials.gov Identifier:
NCT00418704
First received: January 4, 2007
Last updated: September 29, 2013
Last verified: September 2013
  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 2

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


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

Enrollment: 100
Study Start Date: May 2006
Study Completion Date: June 2009
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Erlotinib
    Tarceva (150 mg) is a pill you take once a day -- every day
    Other Name: Erlotinib
    Drug: 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.
    Other Name: Docetaxel
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Site 12
Aix En Provence, France, 13100
Site 22
Beauvais, France, 60021
Site 30
Charleville Mezieres, France, 08000
Site 48
Clermont Ferrand, France, 63000
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 26
Paris, France, 75012
Site 19
Perigueux, France, 24019
Site 02
Reims, France, 51092
Site 20
Rennes, France, 35033
Site 18
Rouen, France, 76031
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
Sanofi
Chugai Pharma USA
Investigators
Principal Investigator: Hervé LECAER, Doctor Groupe Francais De Pneumo-Cancerologie
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Francais De Pneumo-Cancerologie
ClinicalTrials.gov Identifier: NCT00418704     History of Changes
Other Study ID Numbers: GFPC 05-04
Study First Received: January 4, 2007
Last Updated: September 29, 2013
Health Authority: France: Institutional Ethical Committee

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014