A Phase II Study Of Single Agent Depsipeptide (FK228) In Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Efficacy (complete and partial response) according to RECIST
研究概览
简要总结
This phase II trial is studying how well FR901228 works in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. FR901228 may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
详细描述
PRIMARY OBJECTIVES:
I. Determine the efficacy and safety of FR901228 (depsipeptide) in patients with metastatic breast cancer.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this drug, in terms of progression-free survival, in these patients.
OUTLINE: This is a multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed breast cancer
- •Metastatic disease
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •The following are not considered measurable disease:
- •Bone disease only
- •Pleural effusion
- •Peritoneal effusion
- •Must have received prior anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant therapy or for advanced disease
- •Therapy with high-dose regimens or bone marrow transplantation is considered 1 prior regimen
- •No known brain metastases
- •Hormone receptor status:
- •Not specified
- •Male or female
- •Performance status - ECOG 0-1
- •Performance status - Karnofsky 70-100%
- •More than 12 weeks
- •Absolute neutrophil count ≥ 1,500/mm^3
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin normal
- •AST or ALT ≤ 2.5 times upper limit of normal
- •Creatinine normal
- •Creatinine clearance ≥ 60 mL/min
- •QTc < 500 msec
- •No New York Heart Association class III or IV congestive heart failure
- •No myocardial infarction within the past year
- •No uncontrolled dysrhythmia
- •No poorly controlled angina
- •No other significant cardiac disease
- •No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of allergic reaction attributed to compounds of similar chemical or biologic composition to FR901228
- •No active or ongoing infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No concurrent biologic agents
- •No more than 1 prior chemotherapy regimen for metastatic disease
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No prior FR901228 (depsipeptide)
- •No other concurrent chemotherapy
- •Prior hormonal therapy for metastatic disease or as adjuvant therapy allowed
- •More than 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •More than 2 weeks since prior minor surgery and recovered
- •More than 4 weeks since prior major surgery and recovered
- •Concurrent bisphosphonates allowed provided therapy was initiated ≥ 3 months ago
- •No concurrent agents that cause QTc prolongation
- 另有 4 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (romidepsin)
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: romidepsin (Drug)
Treatment (romidepsin)
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Efficacy (complete and partial response) according to RECIST
时间窗: Up to 14 months
Progression-free survival
时间窗: From the first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 14 months
次要结局
- Toxicity as measured by the standard WHO grading system(Up to 14 months after completion of study treatment)