Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00313534|
Recruitment Status : Terminated (Ran out of drug)
First Posted : April 12, 2006
Last Update Posted : October 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: masoprocol||Phase 1|
- Determine the maximum tolerated dose of nordihydroguaiaretic acid (NDGA) in patients with nonmetastatic, biochemically relapsed prostate cancer.
- 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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Official Title:||A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||October 2006|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313534
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Charles Ryan, MD||University of California, San Francisco|