Gefitinib
Drug250 mg/day, until progression
NCT Number: NCT00198393
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
CHU Avicenne - Oncologie, Bobigny, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
250 mg/day, until progression
1250 mg/m² D1 and D8 (D1=D28, until progression)
75 mg/m² D1 (D1=D22, until progression)
Time frame: week
Looking for future studies?
Notify MeIntergroupe Francophone de Cancerologie Thoracique
Other
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