NCT00003008已完成2 期
Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with AIDS-related Kaposi's sarcoma.
详细描述
OBJECTIVES:
- Determine whether the body distribution and plasma clearance of paclitaxel is affected by protease inhibitors (e.g., indinavir, ritonavir, saquinavir mesylate, or nelfinavir mesylate).
OUTLINE: Patients are stratified according to protease inhibitor treatment (yes vs no), prior paclitaxel (yes vs no), and prior doxorubicin or daunorubicin (yes vs no).
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 2 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity. Patients who previously received paclitaxel receive no more than 1 course during this study.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed Kaposi's sarcoma requiring chemotherapy and/or currently being treated with paclitaxel
- •Serologic diagnosis of HIV infection documented by a positive ELISA and confirmed with a Western Blot or other federally approved HIV diagnostic test
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,000/mm ^3(with or without the use of colony-stimulating factors)
- •Platelet count at least 50,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Neurologic:
- •No greater than grade 2 peripheral neuropathy
- •No neuropsychiatric history or altered mental status that would preclude study
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •No sensitivity to E. coli-derived proteins
- •No active untreated infection
- •No new infectious complications requiring a change in antibiotics within the past 2 weeks
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 1 week since prior radiotherapy
- •No prior radiotherapy to marker lesions
- •No concurrent radiotherapy
- •Not specified
- •At least 2 weeks since prior systemic treatment for Kaposi's sarcoma
- •At least 2 weeks since prior nonapproved FDA investigational agents except available Investigational New Drugs that are antiretroviral agents
- •Concurrent maintenance therapy for opportunistic infections allowed
- •Concurrent commercially available antiretroviral therapy allowed
排除标准
- 未提供
研究者
研究点 (1)
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