Clinical trial NCT00198393: Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV
Official title: Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: stage IIIB/IV NSCLC
patients with performance status 2 or 3.
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Sanofi
First posted: 2005-09-20
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: week
Secondary outcomes:
Other outcomes:
Locations:
city: Bobigny
country: France
facility: CHU Avicenne - Oncologie
city: Grenoble
country: France
facility: CHU Grenoble - pneumologie
Study officials:
affiliation: Intergroupe Francophone de Cancerologie Thoracique
name: Jean-Francois Morere, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Intergroupe Francophone de Cancerologie Thoracique
name: Denis Moro-Sibilot, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.