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

NCT ID: NCT00176631

Last Updated: 2023-12-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-05-31

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.

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

licorice root extract and docetaxel

Group Type: EXPERIMENTAL

licorice root extract

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert S. DiPaola, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Countries

United States

Related Links

http://www.clinicaltrials.gov/ct2/show/NCT00176631

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

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0220034593

Identifier Type: OTHER

Identifier Source: secondary_id

CINJ 080306

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000539682

Identifier Type: -

Identifier Source: org_study_id