Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001266
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase II Trial of Leuprolide Flutamide Suramin in Untreated Poor Prognosis Prostate Carcinoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Trial of Leuprolide Flutamide Suramin in Untreated Poor Prognosis Prostate Carcinoma
Status:
COMPLETED
Status Verified Date:
2003-08
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:
One current hypothesis as to what limits duration of initial hormone response is the rapid emergence of hormone resistant prostate carcinoma cells Suramin has shown effectiveness as a treatment for hormonally refractory prostate carcinoma Survival was less in patients with high rather than low circulating androgen levels Thus suramin might slow the emergence of hormone refractory tumor cells while combined androgen ablation may maximize the effectiveness of suramin In this trial we will pilot this concept
Detailed Description:
The purpose of this study is to assess the potential for combined androgen blockage Leuprolide and Flutamide given with suramin a growth factor inhibitor to improve the clinical outcomes in a cohort of patients with bulky metastatic prostate cancer Combined androgen blockage is currently the standard of care for such individuals Suramin has shown reproducible activity in individuals with androgen independent disease Since these two approaches are independent of one another - on the molecular level and in clinical results - it is hoped that the combination of these two approaches will result in improved response rates and in improved survival
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 |
|---|---|---|---|
| 91-C-0014 | None | None | None |