Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT00003256
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Flavopiridol in Treating Patients With Recurrent Prostate Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent prostate cancer after hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Description:
OBJECTIVES:
I. Evaluate the clinical effectiveness of flavopiridol in patients with metastatic androgen independent adenocarcinoma of the prostate.
II. Assess the toxic effects of flavopiridol in this patient population.
OUTLINE:
Patients receive intravenous flavopiridol over 72 hours every 2 weeks for at least 4 courses. After 2 courses of treatment, patients not experiencing unacceptable toxic effects may receive a dose escalation. Patients are followed every 3 months until death.
I. Evaluate the clinical effectiveness of flavopiridol in patients with metastatic androgen independent adenocarcinoma of the prostate.
II. Assess the toxic effects of flavopiridol in this patient population.
OUTLINE:
Patients receive intravenous flavopiridol over 72 hours every 2 weeks for at least 4 courses. After 2 courses of treatment, patients not experiencing unacceptable toxic effects may receive a dose escalation. Patients are followed every 3 months until death.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: