A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have advanced breast cancer.
详细描述
OBJECTIVES:
- Determine the toxicity, including cardiac toxicity, of doxorubicin HCl liposome and trastuzumab (Herceptin) in women with advanced HER-2/neu-overexpressing breast cancer.
- Determine the efficacy of this regimen in these patients.
OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 proven breast cancer
- •Metastatic disease OR
- •Locoregional relapse following optimal adjuvant therapy and regional treatment
- •HER-2/neu overexpression (3+ by immunohistochemistry OR gene amplification by FISH)
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 10 g/dL
- •SGOT and SGPT no greater than 3 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2 times ULN unless documented to be arising from bone
- •Bilirubin no greater than 1.5 times ULN
- •BUN less than 1.5 times ULN
- •Creatinine less than 1.5 times ULN
- •Cardiovascular:
- •LVEF normal by radioisotope method
- •No history of congestive cardiac failure, myocardial infarction, cardiac arrhythmia, or ischemic heart disease requiring medication
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No known sensitivity to benzyl alcohol
- •No other prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior doxorubicin greater than 240 mg/m2
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior radiotherapy to left breast or chest wall allowed
- •Not specified
排除标准
- 未提供