Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004045
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
1999-12-10
Brief Title:
Chemotherapy in Treating Patients With Prostate Cancer
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hormone-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-05
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 Phase II trial to study the effectiveness of DX-8951f in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of DX-8951f in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Determine the antitumor activity of DX-8951f as measured by PSA response in patients with hormone refractory prostate cancer II Determine the antitumor activity of this drug in the subpopulation of these patients with measurable disease III Evaluate the quantitative and qualitative toxicities of this drug in these patients IV Evaluate the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study Patients receive DX-8951f IV over 30 minutes daily for 5 days Courses repeat every 21 days Treatment continues in the absence of unacceptable toxicity or disease progression Patients with no evidence of PSA decrease by the start of course 3 receive no further treatment Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive DX-8951f IV over 30 minutes daily for 5 days Courses repeat every 21 days Treatment continues in the absence of unacceptable toxicity or disease progression Patients with no evidence of PSA decrease by the start of course 3 receive no further treatment Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 12-37 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 |
|---|---|---|---|
| SLLH-BHS-99-0020 | None | None | None |
| DAIICHI-8951A-PRT012 | None | None | None |
| SACI-IDD-99-03 | None | None | None |