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
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Sponsor:
Rutgers, The State University of New Jersey
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
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Study Type | Interventional |
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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 |
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. |
Pre-assignment Details |
Arm/Group Title | Licorice Root Extract and Docetaxel |
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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 | |
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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. |
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Overall Number of Baseline Participants | 10 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
4 40.0%
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>=65 years |
6 60.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 10 participants | |
70 (10.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | |
Female |
0 0.0%
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Male |
10 100.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 10 participants |
10 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
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 |
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 |