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:
University of Medicine and Dentistry New Jersey
Collaborator:
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00176631
First received: September 13, 2005
Last updated: May 9, 2011
Last verified: May 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: licorice root extract Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by University of Medicine and Dentistry New Jersey:
Primary Outcome Measures:
- PSA normalization or decline of 50% [ Time Frame: 6 years ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | September 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176631
Locations
| United States, New Jersey | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
| Principal Investigator: | Robert S. DiPaola, MD | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | Robert DiPaola, MD, UMDNJ/CINJ |
| ClinicalTrials.gov Identifier: | NCT00176631 History of Changes |
| Other Study ID Numbers: | CDR0000539682, P30CA072720, 0220034593, CINJ 080306 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 9, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013