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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 in second-line in old patients with none small cell lung cancer.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Francais De Pneumo-Cancerologie
• Collaborators: Chugai Pharma USA; Sanofi
• Treatments: Docetaxel; Erlotinib Hydrochloride

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