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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.
Full description
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.
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Inclusion and exclusion criteria
Inclusion Criteria
Patients must have:
A. >= 25 mucocutaneous (mouth or skin) lesions. B. Symptomatic visceral involvement. C. Symptomatic lymphedema (pain).
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
Patients with the following prior conditions are excluded:
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:
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Data sourced from clinicaltrials.gov
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