BMS-247550 in Treating Women With Metastatic Breast Cancer
A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant Metastatic Breast Cancer
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 BMS-247550 in treating women who have stage IV or recurrent metastatic breast cancer.
研究概览
详细说明
OBJECTIVES:
- Determine the clinical activity of BMS-247550, in terms of tumor response rate, in women with taxane-resistant metastatic breast cancer.
- Determine the safety of this drug in these patients.
- Determine the duration of response, time to progression, and survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment continues every 3 weeks for 4-18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses beyond CR. Responding patients may receive additional courses at the investigator's discretion.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 12 months.
研究类型
阶段
- 阶段2
联系人和位置
学习地点
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New York
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New York、New York、美国、10021
- Memorial Sloan-Kettering Cancer Center
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New York、New York、美国、10032
- Herbert Irving Comprehensive Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic breast carcinoma
- Stage IV or recurrent disease with distant metastases
Most recent prior chemotherapy was docetaxel-based or paclitaxel-based therapy for metastatic disease
- Progressed during therapy or within 4 months of last dose OR
- Progressed during therapy or within 6 months of last dose if given as adjuvant treatment only
- Received prior anthracycline therapy
Bidimensionally measurable metastatic lesion
- Bony lesions not considered measurable
- No known brain metastases
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Menopausal status:
- Not specified
Sex:
- Female
Performance status:
- ECOG 0-1
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count greater than 125,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases are present)
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months
Other:
- No grade 2 or greater neuropathy (motor or sensory)
- No uncontrolled infection or other medical illness that would preclude study
- No psychiatric disorder or other condition that would preclude study
- No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No hypersensitivity to agents containing Cremophor EL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 24 hours since prior growth factor
- No concurrent trastuzumab (Herceptin)
- No concurrent immunotherapy
Chemotherapy:
- See Disease Characteristics
- No more than 1 prior chemotherapy regimen for metastatic disease except an anthracycline-containing regimen as first-line therapy and a taxane as second-line therapy
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy (except hormone replacement therapy)
Radiotherapy:
- At least 3 weeks since prior radiotherapy, except palliative radiotherapy to less than 20% of the bone marrow, and recovered
- No prior radiotherapy to major bone marrow-containing areas (pelvis and lumbar spine)
- No prior radiotherapy to target lesion if only measurable lesion
- No concurrent therapeutic radiotherapy
Surgery:
- At least 1 week since prior minor surgery
- At least 3 weeks since prior major surgery
- Recovered from prior surgery
Other:
- Recovered from all prior treatment-related toxic effects (alopecia allowed)
- No other concurrent experimental anticancer medications
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
合作者和调查者
调查人员
- 学习椅:Clifford A. Hudis, MD、Memorial Sloan Kettering Cancer Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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