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

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.

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Erlotinib; Drug: taxotere

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Aix En Provence, France, 13100
    • Site 12
  • Beauvais, France, 60021
    • Site 22
  • Charleville Mezieres, France, 08000
    • Site 30
  • Clermont Ferrand, France, 63000
    • Site 48
  • Creteil, France, 94010
    • Site 33
  • Draguignan, France, 83300
    • Site 07
  • Elbeuf, France, 76503
    • Site 32
  • GAP, France, 05000
    • Site 04
  • Le Chesnay, France, 78157
    • Site 41
  • Limoges, France
    • Site 00
  • Mantes La Jolie, France, 78200
    • Site 25
  • Marseille, France, 13274
    • Site 06
  • Martigues, France, 13695
    • Site 27
  • Meaux, France, 77108
    • Site 01
  • Paris, France, 75012
    • Site 26
  • Perigueux, France, 24019
    • Site 19
  • Reims, France, 51092
    • Site 02
  • Rennes, France, 35033
    • Site 20
  • Rouen, France, 76031
    • Site 18
  • Rouen, France, 76233
    • Site 17
  • Toulon, France, 83800
    • Site 14
  • Villefranche Sur Saone, France, 69655
    • Site 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Groupe Francais De Pneumo-Cancerologie
• Collaborators: Sanofi; Chugai Pharma USA
• Investigators: Principal Investigator: Hervé LECAER, Doctor, Groupe Francais De Pneumo-Cancerologie

Publications and helpful links

Helpful Links

• Groupement Francais de Pneumo-cancérologie

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: January 4, 2007
• First Submitted That Met QC Criteria: January 4, 2007
• First Posted (Estimate): January 5, 2007

Study Record Updates

• Last Update Posted (Estimate): October 1, 2013
• Last Update Submitted That Met QC Criteria: September 29, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: cancer; Lung cancer; None small-cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Docetaxel; Erlotinib Hydrochloride
• Other Study ID Numbers: GFPC 05-04