NCT00074139撤回1 期
A Pharmacokinetic Interaction Study Of Docetaxel (Taxotere) 75 mg/mIV On The Combination Therapy Doxorubicin (50 mg/m) And Cyclophosphamide (50 mg/m) In The Treatment Of Advanced Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them at different times, may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase I trial to compare the effectiveness of two regimens of docetaxel combined with doxorubicin and cyclophosphamide in treating women who have advanced breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the pharmacokinetic profile of docetaxel, doxorubicin, and cyclophosphamide in women with advanced breast cancer.
Secondary
- Compare the pharmacokinetic profile of this regimen in these patients vs the historical pharmacokinetic profile of docetaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed advanced breast cancer
- •Adjuvant setting for high-risk disease allowed
- •No symptomatic evidence or history of brain metastases
- •No leptomeningeal metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •Not specified
- •Performance status
- •WHO 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Neutrophil count at least 2,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 10 g/dL
- •Bilirubin less than upper limit of normal (ULN)
- •AST and ALT no greater than 2.5 times ULN (1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN)
- •Alkaline phosphatase no greater than 5 times ULN
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular
- •LVEF or shortening fraction greater than lower limit of normal by MUGA or echocardiography
- •Cardiac function normal
- •No congestive heart failure
- •No unstable angina pectoris
- •No myocardial infarction within the past year
- •No uncontrolled hypertension
- •No high-risk uncontrolled arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective nonhormonal contraception
- •No active uncontrolled infection
- •No active peptic ulcer
- •No unstable diabetes mellitus
- •No other serious illness or medical condition
- •No contraindication to corticosteroids
- •No pre-existing grade 2 or greater motor or sensory neurotoxicity
- •No psychological, social, familial, or geographical reason that would preclude study follow-up
- •No history of significant neurologic or psychiatric disorder (e.g., psychotic disorder, dementia, or seizures) that would preclude understanding and giving informed consent
- •No other neoplasm within the past 10 years except curatively treated nonmelanoma skin cancer, carcinoma in situ of the cervix, ipsilateral ductal carcinoma in situ of the breast, or lobular carcinoma in situ of the breast
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 6 months since prior anthracycline or taxoid (e.g., paclitaxel or docetaxel) therapy
- •No prior cumulative anthracycline dose greater than 240 mg/m^2
- 另有 10 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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