NCT00258375已完成2 期
A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Objective response measured by RECIST criteria after accrual of 14 evaluable patients
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-011 may help docetaxel kill more tumor cells by making tumor cells more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving OGX-011 together with docetaxel works in treating women with locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of OGX-011 and docetaxel, in terms of objective tumor response rate, in women with locally advanced or metastatic breast cancer.
Secondary
- Determine the tolerability and toxicity of this regimen in these patients.
- Determine the time to progression and overall survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（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 or locally advanced disease
- •Not curable with standard therapy
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Lesion must be outside of the previously irradiated field
- •If the sole site of disease is in a previously irradiated field, there must be evidence of disease progression or new lesions in the irradiated field
- •No known CNS metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Platelet count ≥ 100,000/mm^3
- •Absolute granulocyte count ≥ 1,500/mm^3
- •PTT, PT, and INR normal
- •No known bleeding disorder
- •Bilirubin normal
- •AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No significant cardiac dysfunction
- •Immunologic
- •No active uncontrolled infection
- •No history of serious allergic reaction to taxanes, including paclitaxel or docetaxel
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No preexisting neuropathy ≥ grade 2
- •No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- •No other serious medical condition or illness that would preclude study participation
- •No significant neurological disorder that would preclude giving informed consent
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior trastuzumab (Herceptin^®) allowed
- •Chemotherapy
- •Recovered from prior chemotherapy
- •At least 6 months since prior adjuvant chemotherapy (taxanes allowed)
- •At least 4 weeks since prior chemotherapy for advanced disease
- •No prior taxanes for advanced disease
- •No more than 1 prior chemotherapy regimen for advanced disease
- •No other concurrent chemotherapy
- •Endocrine therapy
- •At least 1 week since prior hormonal therapy
- •Radiotherapy
- •See Disease Characteristics
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Objective response measured by RECIST criteria after accrual of 14 evaluable patients
次要结局
- Toxicity
研究者
研究点 (5)
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