Prostate Cancer Clinical Trial
Official title:
A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer
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.
;
Primary Purpose: Treatment
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