Phase II, Open-Label Trial To Assess The Activity Of ZD 1839 (IRESSA) In Patients With Recurrent Prostate Cancer Who Have Rising Serum PSA Levels Despite Serum Testosterone < 50 ng/dL
OBJECTIVES: I. Determine the percentage of patients with recurrent prostate cancer
experiencing at least a 50% decline in prostate-specific antigen (PSA) after receiving ZD
1839. II. Determine the duration of PSA decline in patients treated with this drug. III.
Determine the safety profile of this drug in these patients. IV. Determine the quality of
life of patients treated with this drug. V. Determine the time to progression in patients
treated with this drug. VI. Correlate epidermal growth factor receptor expression with PSA
decline and time to progression in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 twice daily on day 1 and
once daily on days 2-28 of the first course and then once daily on days 1-28 of subsequent
courses. Courses repeat every 28 days for 6 months in the absence of disease progression or
unacceptable toxicity. At the discretion of the pharmaceutical company, patients who show
evidence of prostate-specific antigen response may continue on ZD 1839 as long as they
demonstrate benefit from this treatment extension. Quality of life is assessed at baseline,
before each study course, at completion of study, and then annually during the treatment
extension (if applicable). Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Primary Purpose: Treatment
Fairooz F. Kabbinavar, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government