Double-Blind Randomized Evaluation of Clinical Benefits of DOXIL in Patients With AIDS-Related Kaposi's Sarcoma Treated With DOXIL or DaunoXome
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Lawrence P. Leichman, MD
Study Chair
Albany Medical College
United States: Federal Government
DS 96-28
NCT00002985
November 1996
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |