NCT00054145已完成2 期
A Phase 2 Study Of Perifosine In Metastatic Or Advanced Breast 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
- 4
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 perifosine in treating patients who have recurrent, refractory, locally advanced, or metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the objective tumor response rate in patients with recurrent or refractory, locally advanced or metastatic breast cancer treated with perifosine.
- Determine the toxicity of this drug in these patients.
- Determine the stable disease rate, time to disease progression, objective response duration, and duration of stable disease in patients treated with this drug.
- Correlate potential endpoints, including phosphorylated ERK, PKB, and SAPK, phosphorylated PKC alpha, beta, and gamma isoforms, p21 ^WAF1; and activated capase-3 in tumor biopsies, with clinical outcome in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive a loading dose of oral perifosine on days 1 and 2 and once daily on days 3-21 during course 1. Patients receive oral perifosine once daily on days 1-21 in each subsequent course. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) may receive 2 additional courses beyond the CR.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 6-12 months.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed breast cancer
- •Recurrent or refractory, locally advanced or metastatic disease
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR 10 mm by spiral CT scan
- •Previously irradiated lesions are not considered measurable unless they have demonstrated progression before study entry
- •No measurable disease limited to bone lesions
- •No known brain metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Male or female
- •Menopausal status
- •Not specified
- •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
- •No history of hemolytic disorder
- •Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- •AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No evidence of cardiac dysfunction
- •Gastrointestinal
- •No history of biliary flow obstruction
- •No abnormalities of the gastrointestinal tract that would preclude study drug absorption
- •No active peptic ulcer disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No ongoing or active infection
- •No poorly controlled diabetes mellitus
- •No other uncontrolled illness
- •No prior allergic reactions to compounds of similar chemical or biological composition to perifosine
- •No psychiatric illness or social situation that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- 另有 14 项未显示
排除标准
- 未提供
研究者
研究点 (4)
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