NCT00074100已完成2 期
Amonafide: Individual Phenotype-Adjusted Chemotherapy for Women With Metastatic Breast Cancer Who Have Progressed Despite Prior Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as amonafide, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of amonafide in treating women who have metastatic breast cancer that has progressed after previous chemotherapy.
详细描述
OBJECTIVES:
Primary
- Determine the time to progression in women with metastatic breast cancer who have progressed after prior chemotherapy and are now treated with amonafide.
- Determine the overall response rate (complete and partial response) in patients treated with this drug.
- Determine the safety of a phenotypically driven dosing regimen of this drug in these patients.
Secondary
- Determine the time to tumor response, duration of response, and time to treatment failure in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Determine the pharmacokinetic profile of this drug in these patients.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer
- •Metastatic (stage IV) disease
- •Relapsed after 1 of the following prior therapy regimens*:
- •Adjuvant therapy containing an anthracycline and a taxane
- •Adjuvant anthracycline therapy followed by first-line metastatic treatment containing a taxane NOTE: *No relapse within 12 months of initiation of prior therapy
- •Measurable disease by CT scan or MRI
- •No ascites, pleural effusions, or osteoblastic bone metastases as the only site of measurable disease
- •Refractory to hormonal anticancer therapy completed more than 4 weeks before study therapy
- •HER2/neu positive allowed provided patient received prior trastuzumab (Herceptin®)
- •MUGA or echocardiogram normal while on trastuzumab
- •No known history of or current brain or leptomeningeal metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10.0 g/dL
- •No clinically significant abnormal hematological parameters
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in case of liver metastases)
- •AST or ALT no greater than 2.5 times ULN (5 times ULN in case of liver metastases)
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular
- •See Disease Characteristics
- •No myocardial infarction within the past 3 months
- •No unstable angina pectoris
- •No New York Heart Association class III or IV heart disease
- •No uncontrolled arrhythmia
- •No cardiac insufficiency
- •No uncontrolled hypertension
- •LVEF at least 50% OR at least lower limit of normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception 4 weeks before, during, and for at least 4 weeks after study participation
- •No preexisting neuropathy (motor or sensory) greater than grade 2
- •No clinically significant abnormal biochemical parameters
- •No clinically significant active infection
- •No other prior malignancy except cured nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- •No other serious illness or medical condition
- •No psychological illness or condition that would preclude study participation
- •No other known condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- 另有 23 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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