Status:
COMPLETED
Elderly Dependent Patients With Non Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Groupe Francais De Pneumo-Cancerologie
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
65+ years
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 ...
Detailed Description
A multicenter phase II trial,prospective,randomized,open,non comparative
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00419042
Start Date
July 1 2006
End Date
March 1 2010
Last Update
October 1 2013
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 12
Aix-en-Provence, France, 13100
2
Site 05
Bastia, France, 20200
3
Site 22
Beauvais, France, 60021
4
Site 43
Caen, France, 14000