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

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00176631
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Dietary Supplement: licorice root extract; Drug: docetaxel	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: licorice root extract and docetaxel	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.

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients With PSA Response [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.

Secondary Outcome Measures

1. 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 [7 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08901

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT00176631
• Other Study ID Numbers: CDR0000539682; P30CA072720; 0220034593; CINJ 080306
• First Posted: Sep 15, 2005
• Last Update Posted: Jan 7, 2014
• Last Verified: Nov 1, 2013

• Keywords provided by Rutgers, The State University of New Jersey: adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer
• Additional relevant MeSH terms: Prostatic Neoplasms; Docetaxel

Study Results

Participant Flow

Recruitment Details	Ten subjects were enrolled from April 2004 through November 2006 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center, and one of its affiliate hospitals within the CINJ Oncology Group.

Arm/Group Title	Licorice Root Extract and Docetaxel
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Licorice Root Extract and Docetaxel
Arm/Group Description	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. 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.
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 40%
>=65 years	6 60%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70 (10.3)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	10 100%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.

Arm/Group Title	Licorice Root Extract and Docetaxel
Arm/Group Description	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. 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.
Measure Participants	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.

Arm/Group Title	Licorice Root Extract and Docetaxel
Arm/Group Description	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. 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.
Measure Participants	0

Adverse Events

Time Frame	7 years
Arm/Group Title	Licorice Root Extract and Docetaxel
Arm/Group Description	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. 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.
All Cause Mortality
	Licorice Root Extract and Docetaxel
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Licorice Root Extract and Docetaxel
	Affected / at Risk (%)	# Events
Total	1/10 (10%)
General disorders
Fatigue (lethargy, malaise, asthenia)	1/10 (10%)	1
Psychiatric disorders
Confusion	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Licorice Root Extract and Docetaxel
	Affected / at Risk (%)	# Events
Total	9/10 (90%)
Blood and lymphatic system disorders
Leukocytes (total WBC)	6/10 (60%)	22
Neutrophils/granulocytes (ANC/AGC)	6/10 (60%)	24
Hemoglobin	3/10 (30%)	6
Cardiac disorders
Edema	3/10 (30%)	3
Hypotension	1/10 (10%)	2
Ear and labyrinth disorders
Auditory/Hearing - Other	1/10 (10%)	1
Gastrointestinal disorders
Diarrhea patients without colostomy	3/10 (30%)	5
Anorexia	2/10 (20%)	2
Dehydration	2/10 (20%)	2
Nausea	2/10 (20%)	3
Dysphagia, esophagitis, odynophagia (painful swallowing)	1/10 (10%)	2
Taste disturbance (dysgeusia)	1/10 (10%)	1
Rectal bleeding/hematochezia	1/10 (10%)	1
General disorders
Fatigue (lethargy, malaise, asthenia)	8/10 (80%)	11
Constitutional Symptoms - Other	1/10 (10%)	1
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)	1/10 (10%)	1
Sweating (diaphoresis)	1/10 (10%)	1
Pain	4/10 (40%)	4
Bone pain	1/10 (10%)	1
Infections and infestations
Infection without neutropenia	1/10 (10%)	2
Investigations
Hypermagnesemia	1/10 (10%)	1
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)	1/10 (10%)	1
Nervous system disorders
Neuropathy-sensory	2/10 (20%)	2
Dizziness/lightheadedness	1/10 (10%)	1
Insomnia	1/10 (10%)	1
Psychiatric disorders
Confusion	1/10 (10%)	2
Renal and urinary disorders
Incontinence	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
Cough	2/10 (20%)	2
Dyspnea (shortness of breath)	2/10 (20%)	2
Skin and subcutaneous tissue disorders
Alopecia	1/10 (10%)	1
Dermatology/Skin - Other	1/10 (10%)	1
Rash/desquamation	1/10 (10%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.