Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
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.
Interventions
DIETARY_SUPPLEMENTlicorice 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.
DRUGdocetaxel
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.
Sponsors
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With PSA Response | 9 months | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Ten subjects were enrolled from April 2004 through November 2006 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center, and one of its affiliate hospitals within the CINJ Oncology Group.
Participants by arm
| Arm | Count |
|---|---|
| Licorice Root Extract and Docetaxel 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.
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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Licorice Root Extract and Docetaxel |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 70 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
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.
Time frame: 9 months
Population: No data collected
Secondary
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: 9 months
Population: No data collected