RATIONALE: Nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer.
OBJECTIVES: Primary * Determine the maximum tolerated dose of nordihydroguaiaretic acid (NDGA) in patients with nonmetastatic, biochemically relapsed prostate cancer. Secondary * Determine prostate-specific antigen-modulating effects of NDGA in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral nordihydroguaiaretic acid (NDGA) twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of NDGA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
15
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Dose-limiting toxicity as measured by CTC v3.0
Maximum tolerated dose
Prostate-specific antigen (PSA) at baseline and on day 1 of each course
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