To determine response rate, median time to tumor progression, qualitative and quantitative
toxicity and reversibility of toxicity in patients with advanced refractory AIDS-associated
Kaposi's sarcoma (KS) administered a 3-hour infusion of paclitaxel every 14 days. To
evaluate the clinical benefit of paclitaxel in this patient population by evaluating
self-reported responses to the Symptom Distress Scale and by documenting and evaluating any
changes in their lymphedema, pain and disfiguring facial lesions.
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.
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.
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.
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 taxane therapy.
- At least one systemic chemotherapy regimen that failed to maintain significant
- Intralesional chemotherapy regimens are not considered as prior chemotherapy.
- At least 2 weeks since last dose of prior systemic chemotherapy.