Status:
TERMINATED
Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE2
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, ...
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 * Determi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00176631
Start Date
September 1 2007
End Date
May 1 2008
Last Update
December 22 2023
Active Locations (1)
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1
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901