Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase I trial to determine the effectiveness of genistein in treating patients who have stage II, stage III, or stage IV prostate cancer.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Single and Multiple-Dose Safety and Pharmacokinetic Clinical Study of Genistein in Normal Volunteers and in Prostate Neoplasia (Multiple Dose Safety and Pharmacokinetic Clinical Study of Genistein in Prostate Neoplasia)|
|Study Start Date:||December 1999|
|Study Completion Date:||May 2003|
|Primary Completion Date:||May 2003 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the safety and pharmacokinetics of genistein in patients with stage II, III, or IV prostate cancer.
OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral genistein twice daily. Arm II: Patients receive oral placebo twice daily. Treatment continues for 3 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 6 months.
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center, UNC|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Study Chair:||Leslie Fischer, PhD, MPH, RD||UNC Lineberger Comprehensive Cancer Center|