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.