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

Sponsors and Collaborators:	Cancer Institute of New Jersey National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00176631

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

PSA normalization or decline of 50% [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	September 2003

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 46 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

Sponsors and Collaborators

Cancer Institute of New Jersey

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Robert S. DiPaola, MD

Cancer Institute of New Jersey

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000539682, CINJ-5040, CINJ-4593, CINJ-NJ2805
Study First Received:	September 13, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00176631 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

Adenocarcinoma
Hormones
Prostatic Neoplasms
Recurrence
Licorice

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents

Therapeutic Uses
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009