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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
licorice root extract
docetaxel
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

licorice root extract and docetaxel

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Patients With PSA Response
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
November 15, 2013
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00176631
Brief Title
Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Official Title
A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
licorice root extract and docetaxel
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
licorice root extract
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients With PSA Response
Description
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.
Time Frame
7 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S. DiPaola, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.gov/ct2/show/NCT00176631
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

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

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