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

• ClinicalTrials.gov Identifier: NCT00176631
• Recruitment Status: Terminated
• First Posted: September 15, 2005
• Results First Posted: January 7, 2014
• Last Update Posted: January 7, 2014
• 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

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Prostate Cancer	Dietary Supplement: licorice root extract; Drug: docetaxel	Phase 2

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 30 patients will be accrued for this study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer
• Study Start Date: September 2007
• Actual Primary Completion Date: May 2008
• Actual Study Completion Date: May 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: licorice root extract and docetaxel	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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Patients With PSA Response [ Time Frame: 7 years ]
   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.

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

Locations

United States, New Jersey

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08901

Sponsors and Collaborators

Rutgers, The State University of New Jersey

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Robert S. DiPaola, MD; Rutgers Cancer Institute of New Jersey

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database 

• 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 Posted: September 15, 2005
• Results First Posted: January 7, 2014
• Last Update Posted: January 7, 2014
• Last Verified: November 2013

Keywords provided by Rutgers, The State University of 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; Prostatic Diseases; Docetaxel; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action