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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00176631
Recruitment Status : Terminated (slow accrual)
First Posted : September 15, 2005
Results First Posted : January 7, 2014
Last Update Posted : January 7, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 15, 2005
Results First Submitted Date  ICMJE November 15, 2013
Results First Posted Date  ICMJE January 7, 2014
Last Update Posted Date January 7, 2014
Study Start Date  ICMJE September 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2013)
Percentage of Patients With PSA Response [ Time Frame: 7 years ]
Decline from baseline value by > 50%, or normalization of PSA (defined as PSA less than 0.2 ng/ml), confirmed by a second measurement at least 1 or more weeks later.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Primary Endpoint
  • To determine the efficacy and toxicity of licorice root in combination with docetaxel in patients with hormone-refractory prostate cancer (HRPC).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2013)
Proportion of Patients With a Decrease in BCL-2 Levels in PBMC and in the Degree of Plasma ER Receptor, Between Patients Who Responded to Treatment and Patients Who Did Not [ Time Frame: 7 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Secondary Endpoint(s)
  • To determine the ability of licorice root to alter surrogate markers of estrogen activity and cytotoxicity in patients.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Official Title  ICMJE A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer
Brief Summary

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.

Detailed Description

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 30 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Dietary Supplement: licorice root extract
    Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
  • Drug: docetaxel
    All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle.
Study Arms  ICMJE Experimental: licorice root extract and docetaxel
Interventions:
  • Dietary Supplement: licorice root extract
  • Drug: docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 9, 2011)
10
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
46
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00176631
Other Study ID Numbers  ICMJE CDR0000539682
P30CA072720 ( U.S. NIH Grant/Contract )
0220034593 ( Other Identifier: UMDNJ IRB )
CINJ 080306 ( Other Identifier: CINJ )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Robert S. DiPaola, MD Rutgers Cancer Institute of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP