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A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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.

Inclusion Criteria


- Diagnosis of prostate adenocarcinoma

- Metastatic disease

- Must have failed initial hormonal therapy and have disease progression after at least
one chemotherapy regimen*, meeting any of the following criteria:

- Progressive PSA ≥ 5 ng/mL, as evidenced by 2 separate measurements taken ≥ 2
weeks apart with the second PSA measurement greater than the first one and PSA
measurement at screening greater than the first one

- Progressive measurable disease (e.g., changes in the size of lymph nodes or
parenchymal masses or appearance of new lesions on physical examination or
x-ray/CT scan) with a PSA level at screening ≥ 5 ng/mL

- Progressive bone metastasis (e.g., presence of new lesions on a bone scan) with
a PSA level at screening ≥ 5 ng/mL NOTE: *Prior chemotherapy must include a
taxane therapy, but disease progression does not have to follow taxane therapy

- Patients must maintain primary androgen ablation (hormonal) therapy AND experience
disease progression while not receiving antiandrogen therapy


- ECOG performance status 0-1

- Life expectancy ≥ 6 months

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- WBC ≥ 3,500/mm^3

- Bilirubin ≤ 1.2 mg/dL

- Creatinine ≤ 1.5 mg/dL

- SGOT or SGPT ≤ 1.5 times upper limit of normal

- No other prior malignancy unless treated with curative intent and free of disease for
the time period considered appropriate for the specific cancer

- No uncontrolled hypertension

- No active infections

- No known HIV positivity

- No uncontrolled medical condition that would preclude study therapy

- No diagnosis of major depression or suicidal ideation

- No problems with oral absorption


- See Disease Characteristics

- More than 4 weeks since prior surgery or radiotherapy and recovered

- At least 4 weeks since prior flutamide

- At least 6 weeks since prior bicalutamide

- No prior or concurrent herbal supplements or thiazide diuretics

- No other concurrent investigational or commercial agents or therapies

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA normalization or decline of 50%

Outcome Time Frame:

6 years

Safety Issue:


Principal Investigator

Robert S. DiPaola, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Federal Government

Study ID:




Start Date:

September 2007

Completion Date:

May 2008

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



Cancer Institute of New Jersey New Brunswick, New Jersey  08901