NCT00024414Unknown2 期
Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer
Theradex15 个研究点 分布在 1 个国家开始时间: 2001年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 15
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 DHA-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES:
- Determine the objective tumor response rate or prostate-specific antigen response, duration of response, and time to disease progression in patients with metastatic hormone-refractory prostate cancer treated with DHA-paclitaxel.
- Determine the overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
- Assess the quality of life of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 2 courses, and off 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Progressive metastatic disease on continuous hormonal therapy (e.g., orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist)
- •Progressive disease is defined by all of the following:
- •Measurable disease or lesions on bone scan
- •Increases in prostate-specific antigen (PSA) levels on at least 2 consecutive measurements
- •Continued PSA elevation after cessation of prior antiandrogen therapy (4 weeks after flutamide and nilutamide and 8 weeks after bicalutamide)
- •PSA level at least 5 ng/mL
- •Serum testosterone level less than 50 ng/mL
- •Patients who have not undergone prior surgical castration should continue primary androgen suppression (LHRH agonist)
- •No known or clinical evidence of CNS metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT or SGPT no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No uncontrolled ventricular arrhythmia
- •No myocardial infarction within the past 3 months
- •No superior vena cava syndrome
- •Neurologic:
- •No peripheral neuropathy greater than grade 1
- •No uncontrolled major seizure disorder
- •No spinal cord compression
- •No psychiatric disorder that would preclude informed consent
- •No unstable or serious concurrent medical condition
- •No concurrent serious infection requiring parenteral therapy
- •No other prior or concurrent malignancy except:
- •Curatively treated nonmelanoma skin cancer OR
- •Other cancer curatively treated with surgery alone that has not recurred for more than 5 years
- •Fertile patients must use effective contraception during and for at least 6 months after study therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •No prior taxanes
- •Prior mitoxantrone or prednisone for metastatic disease allowed
- •At least 28 days since prior chemotherapy and recovered
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •No concurrent hormonal therapy
- •Radiotherapy:
- •No prior samarium SM 153 lexidronam pentasodium or strontium chloride Sr 89
- 另有 8 项未显示
排除标准
- 未提供
研究者
研究点 (15)
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