Phase II Study of Celecoxib in HER-2/Neu Overexpressing Metastatic Breast Cancer Patients Who Have Failed Recombinant Humanized Anti-p 185HER Monoclonal Antibody Trastuzumab (HERCEPTIN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Celecoxib may be effective in preventing the further development of cancer. 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 trastuzumab with celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and trastuzumab in treating women who have metastatic breast cancer that has not responded to previous trastuzumab.
详细描述
OBJECTIVES:
- Determine the efficacy of celecoxib and trastuzumab (Herceptin) in women with HER2/neu-overexpressing metastatic breast cancer that is refractory to prior trastuzumab.
- Determine the safety of celecoxib in these patients.
OUTLINE: At least 3 weeks after the last dose of prior chemotherapy, patients receive oral celecoxib twice daily. Patients continue or restart trastuzumab (Herceptin) IV over 30-90 minutes weekly or every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within approximately 9 months.
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 metastatic breast cancer
- •HER2/neu-positive (overexpressing) tumor tissue
- •Failed prior trastuzumab (Herceptin) therapy with or without chemotherapy
- •Resected stage IV disease allowed if evidence of disease
- •Bidimensionally measurable or evaluable disease
- •No lesions in previously irradiated field except nonbone lesions progressive after radiotherapy
- •No pleural effusions
- •No blastic or mixed bony metastases
- •No palpable abdominal masses
- •No leptomeningeal disease
- •Brain metastases allowed if:
- •No concurrent use of steroids
- •At least 3 months since prior brain irradiation
- •No evidence of progression of metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Granulocyte count at least 1,500/mm^3
- •Hemoglobin at least 8.0 g/dL
- •Platelet count at least 100,000/mm^3
- •AST/ALT no greater than 2 times upper limit of normal (ULN)
- •Bilirubin no greater than 1.5 times ULN
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •LVEF at least 50%
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
- •No other serious medical illness
- •No severe infection
- •No severe malnutrition
- •No prior allergic reactions to sulfonamides or celecoxib
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Prior trastuzumab (Herceptin) for breast cancer allowed, either as adjuvant/neoadjuvant or for metastatic disease
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Prior cytotoxic therapy for breast cancer allowed, either as adjuvant/neoadjuvant or for metastatic disease
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排除标准
- 未提供