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Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy - Article


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Biologically based therapies


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

Sponsors and Collaborators: Cancer Institute of New Jersey
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00176631

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

Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures: 
  • PSA normalization or decline of 50%

Total Enrollment:  46

Study start: September 2003

OBJECTIVES:

Primary

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male
Criteria

DISEASE CHARACTERISTICS:

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00176631


Study chairs or principal investigators

Robert S. DiPaola, MD,  Principal Investigator,  Cancer Institute of New Jersey   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000539682; CINJ-5040; CINJ-4593; CINJ-NJ2805
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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October 6, 2008



Page Updated: June 12, 2007
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