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

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176631
First received: September 13, 2005
Last updated: November 15, 2013
Last verified: November 2013

September 13, 2005
November 15, 2013
September 2007
May 2008   (final data collection date for primary outcome measure)
Percentage of Patients With PSA Response [ Time Frame: 7 years ] [ Designated as safety issue: No ]
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.
  • Primary Endpoint
  • To determine the efficacy and toxicity of licorice root in combination with docetaxel in patients with hormone-refractory prostate cancer (HRPC).
Complete list of historical versions of study NCT00176631 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
  • Secondary Endpoint(s)
  • To determine the ability of licorice root to alter surrogate markers of estrogen activity and cytotoxicity in patients.
Not Provided
Not Provided
 
Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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.
Experimental: licorice root extract and docetaxel
Interventions:
  • Dietary Supplement: licorice root extract
  • Drug: docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00176631
CDR0000539682, P30CA072720, 0220034593, CINJ 080306
No
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Robert S. DiPaola, MD Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
November 2013

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