Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003238
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
1999-11-01
Brief Title:
Perillyl Alcohol in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
A Phase II Trial of Perillyl Alcohol NSC 641066 Administered Daily In Patients With Metastatic Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different way to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic prostate cancer that has not responded to hormone therapy with androgens
PURPOSE Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic prostate cancer that has not responded to hormone therapy with androgens
Detailed Description:
OBJECTIVES I Evaluate the clinical effectiveness of oral perillyl alcohol given to patients with androgen independent metastatic prostate cancer II Assess the toxicity of this treatment in these patients
OUTLINE Patients receive oral perillyl alcohol 4 times a day for 4 weeks Patients continue treatment in the absence of severe toxicity and disease progression Patients are followed every 3 months for survival after disease progression
PROJECTED ACCRUAL This study will accrue 20-40 patients in approximately 2 years
OUTLINE Patients receive oral perillyl alcohol 4 times a day for 4 weeks Patients continue treatment in the absence of severe toxicity and disease progression Patients are followed every 3 months for survival after disease progression
PROJECTED ACCRUAL This study will accrue 20-40 patients in approximately 2 years
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 |
|---|---|---|---|
| R03CA073906 | NIH | None | None |
| WCCC-CO-9685 | None | None | None |
| NCI-T97-0067 | US NIH GrantContract | None | httpsreporternihgovquickSearchR03CA073906 |