NCT00020904已完成2 期
A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant 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: 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.
详细描述
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.
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 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:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count greater than 125,000/mm^3
- •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)
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months
- •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
- 另有 6 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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