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

Study start date: March 1, 1999

Inclusion Criteria: Serologic diagnosis of HIV infection as documented by a positive ELISA and confirmed with a western blot, other federally approved HIV diagnostic test, or HIV viral load measurement Biopsy-proven, measurable Kaposi's sarcoma with any of the following: Progressive cutaneous disease Symptomatic oropharyngeal or conjunctival lesions Any visceral involvement Tumor-related lymphedema Tumor-related ulceration or pain NOTE: All patients must have measurable disease; baseline measurements must be obtained < 4 weeks prior to registration ECOG performance status 0-2 ANC >= 1000/mm³ (with or without the use of colony-stimulating factors) Platelet count >= 50,000/mm³ Hemoglobin >= 8 gm/dL Bilirubin < 1.5 x the upper limit of normal (unless elevation is due to Crixivan administration with isolated elevation in conjugated bilirubin) SGOT or SGPT =< 5 x the upper limit of normal Creatinine =< 2.1 mg/dl Women must not be pregnant or lactating due to potential toxicity of therapy Women of childbearing potential and sexually active men must be advised to use an accepted and effective method of contraception due to potential toxicity of therapy No prior systemic cytotoxic chemotherapy for Kaposi's sarcoma Prior radiation therapy must have been discontinued >= 7 days prior to randomization and must NOT have been delivered to marker lesions; (NOTE: Radiation therapy will not be permitted during study treatment) No active, untreated infection (no new opportunistic infectious complications within the previous week requiring a change in antibiotics); maintenance therapy for opportunistic infections will be allowed No prior or concomitant malignancy other than curatively treated carcinoma in situ of the cervix or basal/squamous cell carcinoma of the skin No neuropsychiatric history or altered mental status that might prevent informed consent or affect the ability of the patient to comply with the study Institutions must ask patients to participate in the quality of life portion of the protocol; however, patients may decline participation in this component of the study and still be eligible; the reason for refusal or inability to complete the QOL assessments must be documented in the Assessment Compliance Form (#596) Must not be known to be sensitive to E. coli derived proteins No history of cardiac insufficiency (NY Heart Association status >= 2) Patients must be on stable (no change in drugs or doses) antiretroviral therapy for greater than 14 days prior to study; a combination regimen is required; ideally this will be a protease inhibitor containing triple therapy regimen Patients must give signed, written informed consent