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Double-Blind Randomized Evaluation of Clinical Benefits of DOXIL in Patients With AIDS-Related Kaposi's Sarcoma Treated With DOXIL or DaunoXome

Phase 3
Not Enrolling

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Trial Information

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: AIDS-related Kaposi's sarcoma that requires systemic chemotherapy
One or more of the following (Kaposi's sarcoma- or AIDS-associated): Edema that impairs
functional activity Symptomatic, evaluable pulmonary Kaposi's sarcoma documented within 3
months before study Symptomatic, evaluable GI Kaposi's sarcoma documented within 3 months
before study Moderate or severe pain despite the use of analgesics Lesion(s) that patient
feels are disfiguring and impair patient's self-image or daily activities At least 5
bidimensionally measurable monocutaneous lesions

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 40-100% Life
expectancy: At least 120 days Hematopoietic: Neutrophil count at least 1,200 cells/mm3
Platelet count at least 75,000 cells/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Creatinine
less than 2 times upper limit of normal (ULN) Bilirubin less than 2 times ULN Renal: Not
specified Cardiovascular: Cardiac ejection fraction at least 50% No histopathological
evidence of antracycline-induced cardiomyopathy Pulmonary: No significant non-Kaposi's
sarcoma associated pulmonary insufficiency (defined as oxygen saturation less than 90%)
Other: Not pregnant or nursing Fertile women must be using medically proven method of
birth control No opportunistic infection in the past 4 weeks No other active malignancies
except basal or squamous cell carcinoma of the skin or in situ cervical or anal carcinoma
No neuropsychiatric history or altered mental status that prevents informed consent or
compliance with protocol requirements

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 14 days
since prior anti-Kaposi's sarcoma therapy No prior Doxil or DaunoXome No concurrent
cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent
radiation therapy Surgery: Not specified Other: Antiviral therapy allowed Colony
stimulating factors allowed Erythropoietin allowed Prophylactic therapy, maintenance
therapy and treatment for HIV-associated opportunistic infections allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Lawrence P. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albany Medical College


United States: Federal Government

Study ID:

DS 96-28



Start Date:

November 1996

Completion Date:

Related Keywords:

  • Sarcoma
  • AIDS-related Kaposi sarcoma
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma



Roswell Park Cancer Institute Buffalo, New York  14263