Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002985
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
1999-11-01
Brief Title:
Doxorubicin in Treating Patients With AIDS-Related Kaposis Sarcoma
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Double-Blind Randomized Evaluation of Clinical Benefits of DOXIL in Patients With AIDS-Related Kaposis Sarcoma Treated With DOXIL or DaunoXome
Status:
COMPLETED
Status Verified Date:
2013-02
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 It is not yet known whether doxorubicin is more effective than daunorubicin for AIDS-related Kaposis sarcoma
PURPOSE Randomized double-blinded phase III trial to determine if doxorubicin is more effective than daunorubicin in treating patients who have AIDS-related Kaposis sarcoma
PURPOSE Randomized double-blinded phase III trial to determine if doxorubicin is more effective than daunorubicin in treating patients who have AIDS-related Kaposis sarcoma
Detailed Description:
OBJECTIVES I Evaluate the clinical benefit of doxorubicin HCl liposome Doxil compared to baseline status in the treatment of AIDS-related Kaposis sarcoma II Determine tumor response to Doxil as a corollary to clinical benefit III Evaluate the safety of Doxil
OUTLINE This is a randomized prospective double blind multicenter study Patients are randomly assigned to receive doxorubicin HCl liposome Doxil or daunorubicin DaunoXome in a 31 ratio Both Doxil and DauonoXome are given every 2 weeks for 6 courses by intravenous infusion over 60 minutes into a peripheral vein
PROJECTED ACCRUAL 80 patients will be studied
OUTLINE This is a randomized prospective double blind multicenter study Patients are randomly assigned to receive doxorubicin HCl liposome Doxil or daunorubicin DaunoXome in a 31 ratio Both Doxil and DauonoXome are given every 2 weeks for 6 courses by intravenous infusion over 60 minutes into a peripheral vein
PROJECTED ACCRUAL 80 patients will be studied
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-G97-1241 | None | None | None |
| RPCI-DS-96-28 | None | None | None |
| SEQUUS-30-38 | None | None | None |