Prostate Cancer Clinical Trial
Official title:
A Randomized Phase II Study Of ZD1839 (IRESSA) In Patients With Hormone Refractory Prostate Cancer
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells
and slow the growth of prostate cancer. It is not yet known which dose of ZD 1839 is more
effective in treating prostate cancer that has not responded to hormone therapy.
PURPOSE: Randomized phase II trial to compare different doses of ZD 1839 in treating patients
who have prostate cancer that has not responded to hormone therapy.
OBJECTIVES:
- 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
these regimens.
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
this study.
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