NCT00045097已完成2 期
A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 4
- 主要终点
- Anti-tumor activity as measured by CT scans and bone scans at baseline and every other course
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine any antitumor activity of ixabepilone, in terms of objective response rate, in patients with incurable, locally advanced or metastatic breast cancer.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior taxane therapy (yes vs no).
Patients (with or without prior taxane exposure) receive ixabepilone IV over 1 hour on days 1-5. An additional cohort of 37 patients who have received prior taxane therapy are then accrued to receive ixabepilone IV over 1 hour on days 1-3 at a higher starting dose. For all patients, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who receive more than 6 courses with satisfactory response may be treated every 4-5 weeks.
Patients removed for unacceptable toxicty are followed periodically.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed* adenocarcinoma of the breast
- •Incurable, locally advanced or metastatic disease
- •Primarily stage IV disease, but some inoperable stage III disease may be eligible (e.g., a patient with T4 and/or N2-3 disease who cannot receive doxorubicin or who has already received other therapy) NOTE: *Patients with no available tissue for histologic confirmation but who have documentation of breast surgery and prior chemotherapy are eligible upon approval of the principal investigator
- •Measurable disease
- •No evidence of CNS metastases by brain MRI or contrast head CT scan
- •CNS metastases controlled by radiotherapy or surgical resection at least 6 months prior to study enrollment are allowed
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Female or male
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Granulocyte count at least 1,200/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if there is clinical evidence of Gilbert's disease)
- •AST and ALT no greater than 2.5 times ULN
- •Creatinine normal OR
- •Creatinine clearance greater than 40 mL/min
- •No poor medical risk due to other nonmalignant systemic disease
- •No active uncontrolled infection
- •No sensory, motor, or cranial neuropathy or neuropathic pain grade 2 or greater (unless neuropathy is clearly due to underlying breast cancer)
- •No other concurrent serious medical illness
- •No prior severe hypersensitivity reactions to agents containing Cremophor EL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior filgrastim (G-CSF), pegfilgrastim, or thrombopoietin (or other platelet growth factors)
- •No concurrent immunotherapy
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •No other concurrent chemotherapy for breast cancer
- •Endocrine therapy
- •More than 2 weeks since prior hormonal therapy
- •No concurrent hormonal therapy
- •Radiotherapy
- •See Disease Characteristics
- •No prior craniospinal radiation
- •No prior total body irradiation
- •More than 4 weeks since prior radiotherapy
- •See Disease Characteristics
- •No other concurrent investigational drugs
- •No concurrent cytochrome p450 3A4 inhibitors, including any of the following:
- 另有 20 项未显示
排除标准
- 未提供
结局指标
主要结局
Anti-tumor activity as measured by CT scans and bone scans at baseline and every other course
Ixabepilone toxicity as measured by lab studies at baseline and after every course
次要结局
- Tumor tubulin polymerization and p53 expression from biopsy specimens and cDNA microarray testing at baseline and prior to course 2.
- Neurotoxicity assessment as measured by Semmes-Weinstein monofilament, sharpened Rombrog, one-legged stance, Jebsen Test of hand function, the grooved pef board , and subjective questionnaires at baseline and prior to every other course
研究者
研究点 (4)
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