Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals

Inclusion Criteria Patients must have: Microscopically confirmed diagnosis of KS associated with HIV for which systematic therapy is medically indicated by the presence of at least one of the following: A. >= 25 mucocutaneous (mouth or skin) lesions. B. Symptomatic visceral involvement. C. Symptomatic lymphedema (pain). Minimum of 5 clearly measurably cutaneous lesions by physical exam or measurable disease by X-ray, CT or MRI. Failed at least one systemic chemotherapy regimen. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: Less than 2 weeks since major surgery. Serious uncontrolled infection. NOTE: Must be ruled out by thorough work-up in patients with unexplained fevers, night sweats, or involuntary weight loss of more than 10% normal weight. Leukopenia. Thrombocytopenia. Patients with the following prior conditions are excluded: History of angina or myocardial infarction within the past 6 months. Second degree or third degree atrioventricular block without a pacemaker. Congestive heart failure (poorly controlled). History of prior malignancy except: Completely excised in situ, carcinoma of the cervix or nonmelanomatous skin cancer. Curatively treated other malignancy with no evidence of disease for at least 5 years. Prior Medication: Excluded: Prior taxane therapy. Required: At least one systemic chemotherapy regimen that failed to maintain significant benefit. NOTE: Intralesional chemotherapy regimens are not considered as prior chemotherapy. At least 2 weeks since last dose of prior systemic chemotherapy.