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

NCT00176631 | Terminated Phase 2 Results

• 4 other identifiers: CDR0000539682P30CA0727200220034593CINJ 080306
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With PSA Response

  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.

  9 months

Secondary Outcomes (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

  9 months

Study Arms (1)

licorice root extract and docetaxel

EXPERIMENTAL

Dietary Supplement: licorice root extract; Drug: docetaxel

Interventions

licorice root extract 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.

licorice root extract and docetaxel

docetaxel 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.

licorice root extract and docetaxel

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Glycyrrhiza glabra extract; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Robert DiPaola, MD
• Organization: Rutgers Cancer Institute of New Jersey

dipaolrs@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu

732-235-8675

Study Officials

• Robert S. DiPaola, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 22, 2023
• Results First Posted: January 7, 2014

Record last verified: 2023-12

Locations

US (1)