ZD 1839 in Treating Patients With Recurrent Prostate Cancer
Recruitment status was Active, not recruiting
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of prostate cancer.
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent prostate cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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.
|Study Chair:||Fairooz F. Kabbinavar, MD||Jonsson Comprehensive Cancer Center|