Licorice |
Gan Cao; Glycyrrhiza glabra; Liquorice; Spanish Licorice; Sweet Root |
Clinical Trial: Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) April 2007
Purpose
RATIONALE: Licorice root extract contains ingredients that may slow the growth of tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving licorice root extract together with docetaxel may be an effective treatment for prostate cancer.
PURPOSE: This phase II trial is studying the side effects and how well giving licorice root extract together with docetaxel works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
| Prostate Cancer | Drug: docetaxel Drug: licorice root extract Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: chemotherapy Procedure: complementary and alternative therapy Procedure: herbal medicine / botanical therapy Procedure: nutritional supplementation | Phase II |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer
- PSA normalization or decline of 50%
Total Enrollment: 46
Study start: September 2003
OBJECTIVES:
Primary
- Determine the efficacy and toxicity of licorice root extract in combination with docetaxel in patients with hormone-refractory metastatic prostate cancer.
Secondary
- 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 46 patients will be accrued for this study.
Eligibility
DISEASE CHARACTERISTICS:
-
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
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- 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
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Last Updated: April 18, 2007
Record first received: September 13, 2005
ClinicalTrials.gov Identifier: NCT00176631
Health Authority: Unspecified
ClinicalTrials.gov processed this record on May 08, 2007

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