Clinical trial · Interventional
Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| licorice root extract | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- licorice root extract and docetaxel
- interventionNames
- Dietary Supplement: licorice root extract
- Drug: docetaxel
Primary outcomes (1)
- measure
- Percentage of Patients With PSA Response
- timeFrame
- 9 months
- description
- 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 outcomes (1)
- measure
- 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
- timeFrame
- 9 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available