A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer
- Determine the efficacy and toxicity of licorice root extract in combination with
docetaxel in patients with hormone-refractory metastatic prostate cancer.
- Determine the ability of licorice root extract to alter surrogate markers of estrogen
activity and cytotoxicity in these patients.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral licorice root extract 3
times a day on days 1-21. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA normalization or decline of 50%
Robert S. DiPaola, MD
Cancer Institute of New Jersey
United States: Federal Government
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|