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Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV

NCT ID: NCT00198393

Last Updated: 2010-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-12-31

Brief Summary

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Patients presenting a deterioration of the general state (performance status \[PS\] 2-3), constitute a population which needs an adapted treatment. An analysis was made of the evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594 trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel, docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end of this study, with the analysis of total toxicity, this one was not higher than that noted in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been noted, but the analysis showed that only 2 were due to the treatment. It was noted that the lower survival compared to the others was related to the disease and not to the treatment. These patients are often symptomatic and need palliative treatment. The benefit of chemotherapy should not be denied. They should profit from a monochemotherapy with the new cytotoxic agents, without associated platinum salt.

Detailed Description

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Arm A Iressa 250 mg daily PROG/TOX --\> Taxotere 75 mg/m² d1 (d1=d22)

Arm B Gemzar 1250 mg/m² d1 \& d8 (d1=d22) PROG/TOX --\> Iressa 250 mg daily

Arm C Taxotere 75 mg/m² d1 (d1=d22) PROG/TOX --\> Iressa 250 mg daily

Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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stage IIIB/IV NSCLC patients with performance status 2 or 3.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Gefitinib

Group Type EXPERIMENTAL

Gefitinib

Intervention Type DRUG

250 mg/day, until progression

B

Gemcitabine

Group Type EXPERIMENTAL

gemcitabine

Intervention Type DRUG

1250 mg/m² D1 and D8 (D1=D28, until progression)

C

Docetaxel

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

75 mg/m² D1 (D1=D22, until progression)

Interventions

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Gefitinib

250 mg/day, until progression

Intervention Type DRUG

gemcitabine

1250 mg/m² D1 and D8 (D1=D28, until progression)

Intervention Type DRUG

Docetaxel

75 mg/m² D1 (D1=D22, until progression)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stage IIIB/IV NSCLC
* patients with performance status 2 or 3.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role lead

Responsible Party

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Intergroupe Francophone de Cancérologie Thoracique

Principal Investigators

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Jean-Francois Morere, Pr

Role: PRINCIPAL_INVESTIGATOR

Intergroupe Francophone de Cancerologie Thoracique

Denis Moro-Sibilot, Pr

Role: PRINCIPAL_INVESTIGATOR

Intergroupe Francophone de Cancerologie Thoracique

Locations

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CHU Avicenne - Oncologie

Bobigny, , France

Site Status

CHU Grenoble - pneumologie

Grenoble, , France

Site Status

Countries

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France

References

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Moro-Sibilot D, Pluquet E, Zalcman G, Brechot JM, Souquet PJ, Debieuvre D, Morin F, Morere JF. [What treatment for a patient of PS 2-3 with stage IV non-small cell lung cancer?]. Rev Mal Respir. 2007 Oct;24(8 Pt 2):6S120-4. French.

Reference Type BACKGROUND
PMID: 18235404 (View on PubMed)

Morere JF, Brechot JM, Westeel V, Gounant V, Lebeau B, Vaylet F, Barlesi F, Urban T, Souquet PJ, Debieuvre D, Baudrin L, Zalcman G, Morin F, Milleron B, Moro-Sibilot D. Randomized phase II trial of gefitinib or gemcitabine or docetaxel chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2 or 3 (IFCT-0301 study). Lung Cancer. 2010 Dec;70(3):301-7. doi: 10.1016/j.lungcan.2010.03.003. Epub 2010 Apr 18.

Reference Type RESULT
PMID: 20400201 (View on PubMed)

Related Links

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http://www.ifct.fr

Official website

Other Identifiers

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IFCT-0301

Identifier Type: -

Identifier Source: org_study_id