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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419042
• Other study ID #: GFPC 05-05
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2007
• Last updated: September 29, 2013
• Start date: July 2006
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Groupe Francais De Pneumo-Cancerologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2010
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
France	Site 12	Aix En Provence
France	Site 05	Bastia
France	Site 22	Beauvais
France	Site 43	Caen
France	Site 30	Charleville Mezieres
France	Site 33	Creteil
France	Site 07	Draguignan
France	Site 32	Elbeuf
France	Site 04	GAP
France	Site 41	Le Chesnay
France	Site 00	Limoges
France	Site 25	Mantes La Jolie
France	Site 06	Marseille
France	Site 27	Martigues
France	Site 01	Meaux
France	Site 42	Orleans
France	Site 26	Paris
France	Site 19	Perigueux
France	Site 02	Reims
France	Site 20	Rennes
France	Site 17	Rouen
France	Site 14	Toulon
France	Site 11	Villefranche Sur Saone

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Francais De Pneumo-Cancerologie

Country where clinical trial is conducted

France, 

External Links

•   Groupement Francais de Pneumo-cancérologie