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

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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Dietary Supplement: licorice root extract
Drug: docetaxel
Enrollment 10
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.
Pre-assignment Details  
Arm/Group Title Licorice Root Extract and Docetaxel
Hide 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
Arm/Group Title Licorice Root Extract and Docetaxel
Hide 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 Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  40.0%
>=65 years
6
  60.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
70  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
0
   0.0%
Male
10
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Percentage of Patients With PSA Response
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
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
Hide Description [Not Specified]
Time Frame 7 years
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 7 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Licorice Root Extract and Docetaxel
Hide 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 (%)
Total   --/--    
Hide Serious Adverse Events
Licorice Root Extract and Docetaxel
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
General disorders   
Fatigue (lethargy, malaise, asthenia) * 1  1/10 (10.00%)  1
Psychiatric disorders   
Confusion * 1  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Licorice Root Extract and Docetaxel
Affected / at Risk (%) # Events
Total   9/10 (90.00%)    
Blood and lymphatic system disorders   
Leukocytes (total WBC) * 1  6/10 (60.00%)  22
Neutrophils/granulocytes (ANC/AGC) * 1  6/10 (60.00%)  24
Hemoglobin * 1  3/10 (30.00%)  6
Cardiac disorders   
Edema * 1  3/10 (30.00%)  3
Hypotension * 1  1/10 (10.00%)  2
Ear and labyrinth disorders   
Auditory/Hearing - Other * 1  1/10 (10.00%)  1
Gastrointestinal disorders   
Diarrhea patients without colostomy * 1  3/10 (30.00%)  5
Anorexia * 1  2/10 (20.00%)  2
Dehydration * 1  2/10 (20.00%)  2
Nausea * 1  2/10 (20.00%)  3
Dysphagia, esophagitis, odynophagia (painful swallowing) * 1  1/10 (10.00%)  2
Taste disturbance (dysgeusia) * 1  1/10 (10.00%)  1
Rectal bleeding/hematochezia * 1  1/10 (10.00%)  1
General disorders   
Fatigue (lethargy, malaise, asthenia) * 1  8/10 (80.00%)  11
Constitutional Symptoms - Other * 1  1/10 (10.00%)  1
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) * 1  1/10 (10.00%)  1
Sweating (diaphoresis) * 1  1/10 (10.00%)  1
Pain * 1  4/10 (40.00%)  4
Bone pain * 1  1/10 (10.00%)  1
Infections and infestations   
Infection without neutropenia * 1  1/10 (10.00%)  2
Investigations   
Hypermagnesemia * 1  1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness (not due to neuropathy) * 1  1/10 (10.00%)  1
Nervous system disorders   
Neuropathy-sensory * 1  2/10 (20.00%)  2
Dizziness/lightheadedness * 1  1/10 (10.00%)  1
Insomnia * 1  1/10 (10.00%)  1
Psychiatric disorders   
Confusion * 1  1/10 (10.00%)  2
Renal and urinary disorders   
Incontinence * 1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  2/10 (20.00%)  2
Dyspnea (shortness of breath) * 1  2/10 (20.00%)  2
Skin and subcutaneous tissue disorders   
Alopecia * 1  1/10 (10.00%)  1
Dermatology/Skin - Other * 1  1/10 (10.00%)  1
Rash/desquamation * 1  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert DiPaola, MD
Organization: Rutgers Cancer Institute of New Jersey
Phone: 732-235-8675
EMail: dipaolrs@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu
Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00176631    
Other Study ID Numbers: CDR0000539682
P30CA072720 ( U.S. NIH Grant/Contract )
0220034593 ( Other Identifier: UMDNJ IRB )
CINJ 080306 ( Other Identifier: CINJ )
First Submitted: September 13, 2005
First Posted: September 15, 2005
Results First Submitted: November 15, 2013
Results First Posted: January 7, 2014
Last Update Posted: January 7, 2014