Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
- •Prior taxane therapy.
- •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.