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

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: gemcitabine; Drug: Gefitinib; Drug: Docetaxel

• Registration Number: NCT00198393
• Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

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

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2008-06
• Study Completion: 2008-12
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-28
• Last Update Posted: 2010-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	gemcitabine	Gemcitabine
A	Gefitinib	Gefitinib
C	Docetaxel	Docetaxel

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	week

Trial Locations

Locations (2)

CHU Grenoble - pneumologie; 🇫🇷 Grenoble, France

CHU Avicenne - Oncologie; 🇫🇷 Bobigny, France