NCT00010075Unknown2 期
Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women
GERCOR - Multidisciplinary Oncology Cooperative Group12 个研究点 分布在 1 个国家开始时间: 2000年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 12
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 chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the survival without degradation of quality of life in elderly women with metastatic breast cancer treated with leucovorin calcium, fluorouracil, and mitoxantrone.
- Determine the efficacy of this regimen, in terms of response and survival without progression, in these patients.
- Determine the tolerance of these patients to this regimen.
OUTLINE: This is a multicenter study.
Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1. Patients then receive fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after 3 courses, and at treatment completion.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 75 Years 至 90 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic adenocarcinoma of the breast
- •Bidimensionally measurable or evaluable disease
- •At least one non-irradiated lesion that is at least 2 cm in the greater diameter OR
- •Serous drainage, cutaneous metastasis, osseous metastasis, etc.
- •No symptomatic cerebral metastasis
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status:
- •Postmenopausal
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Platelet count at least 100,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Alkaline phosphatase less than 3 times normal
- •Bilirubin less than 1.5 times normal
- •Transaminases less than 3 times normal
- •Total protein greater than 60%
- •Albumin greater than 30 g/L
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •LVEF greater than 50% by echocardiogram or scintigraph
- •ECG normal
- •No uncontrolled angina
- •No myocardial infarction within past 6 months
- •No other medical illness or condition that would preclude study
- •No other prior malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the cervix
- •No psychological, social, familial, or geographical reasons that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Prior adjuvant chemotherapy allowed
- •No prior adjuvant anthracyclines
- •No prior chemotherapy for metastatic disease
- •Endocrine therapy:
- •One or two prior regimens of hormonal therapy allowed for metastatic disease
- •Radiotherapy:
- •No prior radiotherapy for metastatic disease
- •Not specified
- •No concurrent participation in another study
排除标准
- 未提供
研究者
研究点 (12)
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