This study is a multicentre, open label, non-comparative, two stage phase II trial to assess the activity of ZD1839 (IRESSA) in patients with malignant mesothelioma. Patients will receive trial treatment as first-line therapy, administered continuously once daily until the completion of six 4-week cycles of treatment, disease progression, unacceptable toxicity or withdrawal of consent. Patients continuing to show evidence of response, disease stabilization or clinical benefit from ZD1839 may continue to receive therapy beyond completion of the trail.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
250mg tablet, once daily, orally administered
To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure
Time frame: Proportion of patients responding at trial closure, ITT population
To further characterize the safety profile of ZD1839 at a 250mg daily dose
Time frame: Proportion of patients responding at trial closure, ITT population
To estimate PFS (progression free survival)
Time frame: Proportion of patients alive and progression-free at trial closure, ITT population; Median time to progression or death; Proportion of patients alive and progression-free at 6 months
To estimate overall survival
Time frame: Proportion of patients alive at trial closure, ITT population; Median time to death; Proportion of patients alive at 6 months
To estimate duration of response
Time frame: Median time from objective response to progression or death; only patients who responded are included in this analysis
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