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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.


Phase 2
65 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

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.


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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Hervé LECAER, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Francais De Pneumo-Cancerologie

Authority:

France: Institutional Ethical Committee

Study ID:

GFPC 05-05

NCT ID:

NCT00419042

Start Date:

July 2006

Completion Date:

March 2010

Related Keywords:

  • Non Small Cell Lung Cancer
  • cancer
  • Lung cancer
  • None small-cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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