Sarcoma 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
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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