Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004014
Status:
COMPLETED
Last Update Posted:
2010-08-16
First Post:
1999-11-01
Brief Title:
Liposomal Doxorubicin in Treating Patients With Prostate Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Liposome-Encapsulated Doxorubicin LED in Hormone Refractory Prostate Carcinoma Phase II
Status:
COMPLETED
Status Verified Date:
2010-08
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 ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Estimate the objective response rate of patients with hormone refractory prostate cancer treated with doxorubicin HCl liposome II Determine the toxic effects including any cumulative cardiotoxicity of this regimen in these patients III Assess the effect of this regimen on pain and quality of life of these patients
OUTLINE Patients receive doxorubicin HCl liposome IV over 45 minutes every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and then every 9 weeks thereafter Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 50 evaluable patients will be accrued for this study
OUTLINE Patients receive doxorubicin HCl liposome IV over 45 minutes every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and then every 9 weeks thereafter Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 50 evaluable 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 |
|---|---|---|---|
| NCI-G99-1558 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-NEO-1898 | None | None | None |
| NEOPHARM-LED-P2 | None | None | None |