NCT00060437已完成2 期
A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have prostate cancer that no longer responds to androgen ablation therapy.
详细描述
OBJECTIVES:
- Determine the 4-month progression-free survival rate, as measured by prostate-specific antigen and clinical criteria, in patients with metastatic androgen-independent prostate cancer treated with perifosine.
- Determine the side-effect profile of this drug in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
OUTLINE:
- Course 1: Patients receive oral perifosine twice on day 1 and once daily on days 2-21.
- All subsequent courses: Patients receive oral perifosine once daily on days 1-21.
In all courses, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 confirmed adenocarcinoma of the prostate, meeting all of the following criteria:
- •Metastatic
- •Androgen-independent
- •Progressive disease while continuing to receive hormonal ablation (e.g., luteinizing hormone-releasing hormone [LHRH] agonist)
- •Progression documented by at least 1 of the following parameters:
- •Two consecutively rising prostate-specific antigen levels, at least 1 week apart, with at least 1 measurement that is 50% above the nadir reached after the last treatment regimen (as long as the last measurement is at least 5 ng/mL)
- •At least 1 new metastatic lesion on technetium Tc 99m bone scintigraphy
- •Progression of soft-tissue metastases as measured by appropriate modalities (i.e., imaging or palpation) and demonstrated by at least 1 of the following:
- •Development of new area of malignant disease (measurable or nonmeasurable)
- •At least a 20% increase in the sum of the longest diameters (LD) of target lesions from the smallest sum of LD recorded since the treatment started or the appearance of 1 or more new lesions
- •Patients who have not undergone surgical castration must have a testosterone level less than 50 ng/mL and continue on their LHRH agonist during study treatment
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 1.0 mg/dL or upper limit of normal (ULN)
- •AST/ALT no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular
- •No myocardial infarction within the past 6 months
- •No unstable or newly diagnosed angina pectoris
- •No New York Heart Association class II-IV congestive heart failure
- •No pre-existing retinal disease
- •No pathologic baseline electrooculogram
- •Fertile patients must use effective barrier contraception
- •Able to ingest oral medication
- •No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine (e.g., miltefosine or edelfosine)
- •No ongoing or active infection
- •No other concurrent uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •No other active malignancies within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No more than 1 prior chemotherapy regimen
- •More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin)
- •Endocrine therapy
- •See Disease Characteristics
- •More than 4 weeks since prior flutamide
- 另有 11 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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