NCT00087620终止4 期
A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 试验地点
- 35
研究概览
简要总结
To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2 twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily) until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W).
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
- •Have provided written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- •Be female and at least 18 years of age. Note: must be 19 years of age if the patient is a resident of the state of Alabama
- •Be ambulatory (outpatient) and have a Karnofsky performance status of more than 70%
- •Have confirmed breast cancer with locally advanced and/or metastases
- •Have at least one site with defined tumor
- •Have met one of the study definitions of primary or nonprimary resistance to an anthracycline-containing therapy
排除标准
- •Pregnant/lactating women
- •Women of childbearing potential with either a positive or no pregnancy test
- •Women of childbearing potential unless using a reliable and appropriate contraceptive method (Postmenopausal women must have not had their period for at least 12 months to be considered of non-childbearing potential)
- •Prior treatment with chemotherapy in the advanced/metastatic setting
- •HER 2/neu positive status without prior treatment with trastuzumab
- •Prior treatment with IV bolus 5-FU, continuous 5-FU infusion, capecitabine or other oral fluoropyrimidines
- •Prior treatment with a taxane if less than 12 months passed from the time of therapy completion to relapse
- •Mitomycin C or nitrosoureas within 6 weeks preceding treatment start
- •Organ allografts requiring immunosuppressive therapy
- •Radiotherapy to the skeleton within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiotherapy
- •Hormonal therapy within 10 days preceding study treatment start
- •Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery
- •Blood transfusions/growth factors to aid hematologic recovery within 2 weeks prior to study treatment start
- •Participation in any investigational drug study within 4 weeks preceding treatment start
- •Prior unanticipated severe reaction to fluoropyrimidine therapy
- •Known hypersensitivity to 5-fluorouracil, taxanes or any of the components of capecitabine
- •Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues
- •Evidence of CNS metastases
- •History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma
- •Clinically significant (i.e. active) cardiac disease
- •Abnormal laboratory values
- •Severe renal impairment
- •Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
- •Lack of physical integrity of the upper GI tract
- •Life expectancy of less than 3 months
- •Unwilling/unable to comply with the protocol
研究者
研究点 (35)
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