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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:
National Cancer Institute (NCI)
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
History of Changes
Results First Received: November 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Dietary Supplement: licorice root extract
Drug: docetaxel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Licorice Root Extract and Docetaxel

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.

Participant Flow:   Overall Study
    Licorice Root Extract and Docetaxel  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Licorice Root Extract and Docetaxel

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.

Baseline Measures
    Licorice Root Extract and Docetaxel  
Number of Participants  
[units: participants]
 		  10  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     6  
Age  
[units: years]
Mean (Standard Deviation) 		  70  (10.3)  
Gender  
[units: participants]
 		 
Female     0  
Male     10  
Region of Enrollment  
[units: participants]
 		 
United States     10  



  Outcome Measures
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1.  Primary:   Percentage of Patients With PSA Response   [ Time Frame: 7 years ]
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2.  Secondary:   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 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Robert DiPaola, MD
Organization: Rutgers Cancer Institute of New Jersey
phone: 732-235-8675
e-mail: dipaolrs@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu



Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00176631     History of Changes
Other Study ID Numbers: CDR0000539682
P30CA072720 ( US NIH Grant/Contract Award Number )
0220034593 ( Other Identifier: UMDNJ IRB )
CINJ 080306 ( Other Identifier: CINJ )
Study First Received: September 13, 2005
Results First Received: November 15, 2013
Last Updated: November 15, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board