Prostate Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT00176631

Recruitment Status:

Terminated

Sponsor:

Rutgers, The State University of New Jersey

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT00176631

Recruitment Status:

Terminated

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.