Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176631
Status:
TERMINATED
Last Update Posted:
2023-12-22
First Post:
2005-09-13
Brief Title:
Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA072720 | NIH | None | None |
| 0220034593 | OTHER | None | None |
| CINJ 080306 | OTHER | CINJ | httpsreporternihgovquickSearchP30CA072720 |