Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005827
Status:
WITHDRAWN
Last Update Posted:
2012-04-24
First Post:
2000-06-02
Brief Title:
Genistein in Treating Patients With Stage II Stage III or Stage IV Prostate Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Single and Multiple-Dose Safety and Pharmacokinetic Clinical Study of Genistein in Normal Volunteers and in Prostate Neoplasia Multiple Dose Safety and Pharmacokinetic Clinical Study of Genistein in Prostate Neoplasia
Status:
WITHDRAWN
Status Verified Date:
2012-04
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 ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Randomized phase I trial to determine the effectiveness of genistein in treating patients who have stage II stage III or stage IV prostate cancer
PURPOSE Randomized phase I trial to determine the effectiveness of genistein in treating patients who have stage II stage III or stage IV prostate cancer
Detailed Description:
OBJECTIVES I Determine the safety and pharmacokinetics of genistein in patients with stage II III or IV prostate cancer
OUTLINE This is a randomized double blind placebo controlled study Patients are randomized to one of two treatment arms Arm I Patients receive oral genistein twice daily Arm II Patients receive oral placebo twice daily Treatment continues for 3 months in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 6 months
OUTLINE This is a randomized double blind placebo controlled study Patients are randomized to one of two treatment arms Arm I Patients receive oral genistein twice daily Arm II Patients receive oral placebo twice daily Treatment continues for 3 months in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 6 months
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 |
|---|---|---|---|
| CDR0000067840 | OTHER | PDQ number | None |
| UNC-GCRC-1203 | None | None | None |
| NCI-G00-1788 | None | None | None |