Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma
|ClinicalTrials.gov Identifier: NCT00002985|
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : February 4, 2013
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 Kaposi's sarcoma.
PURPOSE: Randomized double-blinded phase III trial to determine if doxorubicin is more effective than daunorubicin in treating patients who have AIDS-related Kaposi's sarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: daunorubicin hydrochloride Drug: pegylated liposomal doxorubicin hydrochloride||Phase 3|
OBJECTIVES: I. Evaluate the clinical benefit of doxorubicin HCl liposome (Doxil) compared to baseline status in the treatment of AIDS-related Kaposi's 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 3:1 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 Type :||Interventional (Clinical Trial)|
|Official Title:||Double-Blind Randomized Evaluation of Clinical Benefits of DOXIL in Patients With AIDS-Related Kaposi's Sarcoma Treated With DOXIL or DaunoXome|
|Study Start Date :||November 1996|
|Actual Primary Completion Date :||January 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002985
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Lawrence P. Leichman, MD||Albany Medical College|