Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00313534
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity as measured by CTC v3.0
- Secondary Outcome Measures
Name Time Method Maximum tolerated dose Prostate-specific antigen (PSA) at baseline and on day 1 of each course
Trial Locations
- Locations (1)
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
UCSF Comprehensive Cancer Center🇺🇸San Francisco, California, United States