Status:
COMPLETED
Elderly Independent Patients With Non Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Groupe Francais De Pneumo-Cancerologie
Collaborating Sponsors:
Sanofi
Chugai Pharma USA
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
65+ years
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 i...
Detailed Description
A multicenter phase II trial , prospective, randomized, open, non comparative
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00418704
Start Date
May 1 2006
End Date
June 1 2009
Last Update
October 1 2013
Active Locations (22)
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1
Site 12
Aix-en-Provence, France, 13100
2
Site 22
Beauvais, France, 60021
3
Site 30
Charleville-Mézières, France, 08000
4
Site 48
Clermont-Ferrand, France, 63000