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	Treatment or Intervention	Phase
epidemic Kaposi's sarcoma childhood skin cancer	Drug: daunorubicin  Drug: doxorubicin HCl liposome	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY 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

--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

--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

New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

Study chairs or principal investigators

Lawrence P. Leichman,  Study Chair,  Roswell Park Cancer Institute   

Study ID Numbers:  CDR0000065520; RPCI-DS-96-28; NCI-G97-1241; SEQUUS-30-38
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002985
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08