Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: licorice root extract; docetaxel
Intervention description: 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.; 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 MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer

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.
    

Eligibility 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