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

A Multicenter Randomized Phase II Trial in NSCLC Stage IV et IIIB in Elderly Dependent Patients With Evaluation of the Sequence Gemcitabine First Line Followed by Erlotinib When Progression Versus Erlotinib First Line Followed by Gemcitabine When Progression.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00419042

Enrollment

100

Registered

2007-01-05

Start date

2006-07-31

Completion date

2010-03-31

Last updated

2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

cancer, Lung cancer, None small-cell lung cancer

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 Erlotinib when progression versus Erlotinib first line followed by Gemcitabine when progression

Detailed description

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

Interventions

DRUGTARCEVA

Tarceva (150 mg) is a pill you take once a day -- every day -- to help treat non-small cell lung cancer.

DRUGGemzar

GEMZAR by mixing it into a solution and giving it through a needle into a vein-called intravenous infusion (IV). This will take about 30 minutes

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 criteria

* 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026