A Randomized Phase II Study Of ZD1839 (IRESSA) In Patients With Hormone Refractory Prostate Cancer
- Compare the efficacy of 2 different doses of ZD 1839, in terms of objective response,
PSA response, and duration of response, in patients with hormone-refractory
adenocarcinoma of the prostate.
- Compare the tolerability and quantitative toxicity of these regimens in these patients.
- Determine whether there is an association between any response or stable disease and
clinical benefit as assessed by changes in quality of life of patients treated with
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
measurable disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral, low-dose ZD 1839 twice daily on day 1 and once daily on
days 2-28 during course 1 and then once daily on days 1-28 during subsequent courses.
- Arm II: Patients receive oral, high-dose ZD 1839 as in arm I. Treatment in both arms
continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at the end of each course during study, and then at
4 weeks after study.
Patients with stable or responding disease are followed at 4 weeks and then every 3 months
until disease progression. All other patients are followed at 4 weeks only.
PROJECTED ACCRUAL: A total of 30-60 patients (15-30 per treatment arm) will be accrued for
Allocation: Randomized, Primary Purpose: Treatment
Malcolm J. Moore, MD
Princess Margaret Hospital, Canada
United States: Federal Government