NCT00146588已完成不适用
A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer
Craig A. Bunnell, MD, MPH4 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2002年4月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer.
研究概览
简要总结
The purpose of this study is to find out what effects (good and bad) a combination of cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.
详细描述
- Each treatment cycle lasts 21 days and patients will participate in a least 4 cycles, but no more than 6 cycles of treatment.
- Patients will receive cytoxan (cyclophosphamide) and epirubicin intravenously on day 1 of each treatment cycle. On days 4-17 of each cycle, patients will take capecitabine orally twice a day.
- While on the study patients will be required to complete a diary of they capecitabine treatment.
- Blood tests will be performed each week along with surveys at the beginning of the trial and certain follow-up visits to evaluate the patient's experience with the oral chemotherapy.
- Patients will be on the treatment for 12-18 weeks depending upon whether or not the disease progresses or the patient develops inacceptable side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Stage I-III breast cancer. If Stage I, should be deemed of sufficiently high risk of developing recurrent disease to warrant participation.
- •18 years of age or older
- •ANC > 1,000/mm3
- •Platelet count > 100,000/mm3
- •Hemoglobin > 10
- •Creatinine < 2.0
- •SGOT < 2 x ULN
- •Bilirubin < 1.5mg/dl
- •Able to swallow and retain oral medication
- •LVEF greater than or equal to 50%
- •ECOG performance status of 0 or 1
排除标准
- •Pregnant or lactating
- •Prior malignancy within 5 years (excluding squamous or basal cell skin cancers)
- •Prior chemotherapy within 5 years
- •Prior anthracycline therapy
- •Serious comorbid physical or psychological condition
结局指标
主要结局
To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer.
时间窗: 2 years
次要结局
未报告次要终点
研究者
Craig A. Bunnell, MD, MPH
Associate Chief Medical Officer
Dana-Farber Cancer Institute
研究点 (4)
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