NCT00028639已完成2 期
A Phase II Study of the Proteasome Inhibitor PS-341 (NSC 681 239) in Patients With Metastatic 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
- 2
研究概览
简要总结
RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the objective tumor response in women with metastatic breast cancer treated with bortezomib.
- Determine the toxic effects of this drug in these patients.
- Determine the progression-free survival in patients treated with this drug.
OUTLINE: Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 6-24 months.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the breast
- •Metastatic disease
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •Previously treated with 1 prior chemotherapy regimen (with or without trastuzumab [Herceptin]) for metastatic disease
- •Relapse during or within 6 months after completion of adjuvant chemotherapy considered treatment failure
- •No known brain metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •SGOT/SGPT no greater than 2.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No uncontrolled concurrent illness
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib
- •No other prior malignancy within the past 5 years unless curatively treated and disease free
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Endocrine therapy:
- •Prior hormonal therapy for metastatic disease allowed
- •At least 4 weeks since prior hormonal therapy and recovered
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •Not specified
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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