NCT00049244Unknown1 期
A Phase I Study of BMS-247550 in Combination With Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With a Taxane and an Anthracycline
R-Pharm2 个研究点 分布在 1 个国家开始时间: 2002年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 2
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of BMS-247550 and capecitabine, on 2 different schedules, in patients with metastatic breast cancer previously treated with a taxane and an anthracycline.
- Determine the safety profile of this regimen in these patients.
- Determine, preliminarily, any antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups.
- Group I: Patients receive BMS-247550 IV over 3 hours on day 1 and oral capecitabine twice daily on days 1-14.
- Group II: Patients receive BMS-247550 IV over 1 hour on days 1-3 and capecitabine as in group I.
Treatment in both groups repeats every 3 weeks for 2-18 courses in the absence of disease progression or unacceptable toxicity.
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 120 Years（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
- •Metastatic disease by radiography or histology
- •Must have received prior chemotherapy with a taxane and an anthracycline in the adjuvant or metastatic setting
- •No more than 2 prior chemotherapy regimens in the metastatic setting
- •Measurable or evaluable disease
- •Bone lesions not measurable
- •Primary breast lesions not measurable if assessed only by physical exam
- •No active brain metastasis
- •No cerebral edema by CT scan or MRI
- •No progression since prior imaging studies
- •No requirement for steroids
- •No clinical symptoms of brain metastasis
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Not specified
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT no greater than 2.5 times ULN
- •Creatinine less than 1.5 times ULN
- •Cardiovascular
- •No uncontrolled or significant cardiovascular disease
- •No myocardial infarction within the past year
- •No uncontrolled angina within the past year
- •No history of congestive heart failure
- •No history of atrial or ventricular arrhythmias
- •No history of second- or third-degree heart block
- •No uncontrolled hypertension
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No hypersensitivity to Cremophor EL or fluorouracil
- •No prior intolerance to fluoropyrimidines
- •No other serious uncontrolled medical disorder or active infection that would preclude study
- •No dementia or altered mental status that would preclude study
- •No grade 2 or greater neuropathy (neuromotor or neurosensory)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Chemotherapy
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排除标准
- 未提供
研究者
研究点 (2)
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