NCT00324610Unknown1 期
Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2006年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 46
- 试验地点
- 1
研究概览
简要总结
Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity.
Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen.
Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen
研究设计
- 研究类型
- Interventional
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 proven breast adenocarcinoma
- •Evaluable or measurable metastases
- •HER-2 status 0 or 1 in immnohistochimy or negative in FISH/CISH
- •Previously treated with anthracyclines and taxanes
- •Age > = 18 y
- •No more than two previous chemotherapy regimens for metastases
- •No nervous central system involvement
- •Hormonal therapy must have been stopped two weeks before enrollment
- •Adequate biologic function
- •Performance status OMS < = 2
- •Signed informed consent
排除标准
- •History of other malignancies, except basocellular cancer, in situ cervix carcinoma
- •Gastro intestinal disease that might affect absorption of capecitabine
- •Cardiac failure or angina pectoris uncontrolled
- •Hypersensitivity for capecitabine, fluorouracil, or one of their excipient
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Concomitant anticancer therapy (included hormonotherapy)
- •Concomitant radiotherapy
- •Treatment with sorivudine and analogs
- •Pregnant or breast feeding patients. Contraception methods excluding hormonal treatment is required.
- •Inclusion in an experimental protocol within 30 days
研究者
研究点 (1)
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