This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
To compare ZD1839 and vinorelbine in terms of progression free survival
To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.
To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.
To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.
To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.
To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring
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Research Site
St Leonards, New South Wales, Australia
Research Site
Westmead, New South Wales, Australia
Research Site
South Brisbane, Queensland, Australia
Research Site
Nedlands, Western Australia, Australia
Research Site
Victoria, Australia
Research Site
Fortaleza, Ceará, Brazil
Research Site
Goiânia, Goiás, Brazil
Research Site
Rio de Janeiro, Rio de Janeiro, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
Prague, CZ, Czechia
...and 45 more locations