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

Groupe Francais De Pneumo-Cancerologie

Status: Completed

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: taxotere; Drug: Erlotinib

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00418704

GFPC 05-04

Details and patient eligibility

About

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.

Full description

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

Enrollment: 100 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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