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

A Multicenter Randomized Phase II Trial in NSCLC Stage IV and IIIB (T4 With Pleural Effusion) in Elderly Independent Patients the Schedule Docetaxel / Gemcitabine First Line Following by Erlotinib When Progression Versus Erlotinib First Line Following by/ Gemcitabine When Progression.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00418704

Enrollment

100

Registered

2007-01-05

Start date

2006-05-31

Completion date

2009-06-30

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 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.

Detailed description

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

Interventions

DRUGErlotinib

Tarceva (150 mg) is a pill you take once a day -- every day

DRUGtaxotere

Taxotere® (docetaxel) is given intravenously (I.V.) into the vein. Taxotere® chemotherapy treatment takes about one hour, and usually people receive treatments every three weeks.

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 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

Countries

France

Outcome results

None listed

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