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

Patients are treated with paclitaxel intravenously every 2 weeks up to 10 courses. Patients who achieve a complete response receive 2 additional courses those who achieve partial response or stabilization, continue therapy until progression.

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.