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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groupe Francais De Pneumo-Cancerologie
ClinicalTrials.gov Identifier:
NCT00419042
First received: January 4, 2007
Last updated: September 29, 2013
Last verified: March 2010
  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 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 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.

Resource links provided by NLM:


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

Enrollment: 100
Study Start Date: July 2006
Study Completion Date: March 2010
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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
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
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: NCT00419042

Locations
France
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
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: NCT00419042     History of Changes
Other Study ID Numbers: GFPC 05-05
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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014