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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.


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 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.


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


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

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 05-04

NCT ID:

NCT00418704

Start Date:

May 2006

Completion Date:

June 2009

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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