A Phase I Study of Weekly Administration of Oral Navelbine in Combination With the COX-2 Inhibitor Celebrex in Relapsed and/or Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer.
研究概览
简要总结
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vinorelbine with celecoxib may kill more tumor cells.
PURPOSE: Phase I trial to determine the effectiveness of combining vinorelbine with celecoxib in treating women who have relapsed or metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer.
- Determine the safety profile of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral celecoxib twice daily on days 1-21 and oral vinorelbine on days 7, 14, and 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of celecoxib and vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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 adenocarcinoma of the breast
- •Recurrent or metastatic (stage IV) disease
- •Incurable disease
- •Measurable or evaluable disease
- •Stable brain metastases allowed
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8.0 g/dL
- •Bilirubin normal
- •AST/ALT ≤ 2.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance ≥ 60 mL/min
- •No clinically significant proteinuria
- •No impaired renal function
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina
- •No cardiac arrhythmia
- •No inadequately controlled hypertension
- •Gastrointestinal
- •No disorder that would alter gastrointestinal motility or absorption
- •No dysphagia
- •Able to swallow tablets or capsules
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No hypersensitivity to celecoxib
- •No prior urticaria, asthma, or other allergic-type reaction after taking aspirin or other nonsteroidal anti-inflammatory drugs
- •No allergy to sulfa
- •No other concurrent uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •No ongoing or active infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 3 weeks since prior trastuzumab (Herceptin®) and recovered
- •No concurrent hematopoietic growth factors
- •Chemotherapy
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Prior adjuvant or neoadjuvant chemotherapy allowed
- 另有 18 项未显示
排除标准
- 未提供
结局指标
主要结局
Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer.
时间窗: Courses (21 days) repeat every 21 days in the absence of disease progression or unacceptable toxicity.
次要结局
未报告次要终点