Phase III Study of Paclitaxel Versus Liposomal Doxorubicin for the Treatment of Advanced AIDS-Associated Kaposi’s Sarcoma

Pts must have serologic dx of HIV infection. Pt must have biopsy proven measurable KS w/any of the following: progressive cutaneous disease, symptomatic oropharyngeal or conjunctival lesions, visceral involvement, tumor-related lymphedema, tumor-related ulceration or pain. Baseline mx must be obtained less than/equal to 4 wks prior to reg. Pt must be 18 years or older w/ECOG PS of 0-2. The following lab criteria must be obtained less than/equal 4 wks prior to rand: ANC greater than/equal 1000, PLT greater than/equal 50,000, HGB greater than/equal 8 gm/dl, bilirubin less than 1.5 x the ULN, SGOT or SGPT less than/equal 5 x the ULN and creatinine less than/equal 2.1 mg/dl. Women must not be pregnant or lactating. Pt must have had no prior systemic cytotoxic chemo for KS. Prior RT must have been d/c'ed greater than/equal 7 days prior to rand and must NOT have been delivered to marker lesions. Pt must have no active, untreated infection. Pt must have no prior or concomitant malignancy other than curatively treated CIS of the cervix or basal/squamous cell carcinoma of the skin. Pts must not be known to be sensitive to E. Coli derived proteins. Pt must have no history of cardiac insufficiency (NY Heart Assoc Status greater than/equal 2). Pt must be on stable antiretroviral tx for greater than 14 days prior to study.