NCT00039520已完成2 期
A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic Adenocarcinoma Of The Breast
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
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 II trial to study the effectiveness of combining sulindac with docetaxel in treating women who have metastatic or recurrent breast cancer.
详细描述
OBJECTIVES:
- Determine the response rate of women with metastatic or recurrent adenocarcinoma of the breast treated with sulindac and docetaxel.
- Determine the time to progression of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive oral sulindac twice daily. Patients also receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed within 3-4 weeks.
PROJECTED ACCRUAL: Approximately 12-33 patients will be accrued for this study.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the breast
- •Metastatic or recurrent disease
- •Measurable disease
- •Bone only disease is not eligible
- •No hematologic malignancy
- •No carcinomatous meningitis and/or untreated or uncontrolled brain parenchymal disease
- •At least 8 weeks since prior therapy for brain parenchymal disease and patient must be asymptomatic from CNS disease
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Premenopausal or postmenopausal
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than upper limit of normal (ULN)
- •One of the following:
- •SGOT and SGPT no greater than 2.5 times ULN AND
- •Alkaline phosphatase no greater than ULN OR
- •SGOT and SGPT no greater than ULN AND
- •Alkaline phosphatase no greater than 4 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No unstable angina
- •No uncontrolled atrial or ventricular arrhythmias
- •No congestive heart failure
- •No uncontrolled hypertension
- •No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or contralateral breast cancer
- •No active unresolved infection
- •No poorly controlled diabetes mellitus
- •No prior hypersensitivity reactions to sulindac or Polysorbate 80
- •No peripheral neuropathy grade 2 or greater
- •No active peptic ulcer disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy
- •No concurrent biological response modifiers
- •No concurrent trastuzumab (Herceptin)
- •Chemotherapy:
- •No more than 1 prior chemotherapy regimen in the adjuvant setting
- •No more than 1 prior chemotherapy regimen for recurrent or metastatic disease
- 另有 20 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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