NCT00589901Unknown2 期
Phase II Study of an All-Oral Combination of Capecitabine (X) and Cyclophosphamide (C) in Patients With Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- TTP (first treatment of this regimen to disease progression)
研究概览
简要总结
The primary objective of this study is to evaluate the time to progression. Secondary objectives are safety, OS and pharmacogenetic analysis. Sixty patients will be enrolled into this study.
详细描述
Xeloda (capecitabine) is converted to 5-fluorouracil by thymidine phosphorylase, and cyclophosphamide is capable of upregulating the expression of thymidine phosphorylase suggesting a synergistic effect.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed breast cancer
- •Anthracycline and taxane pretreated metastatic breast cancer
- •Have not been previously treated with capecitabine
- •ECOG performance status of ≤ 1
- •Are female and ≥ 18 and ≤ 70 years of age
- •Have at least one target lesion according to the RECIST criteria
排除标准
- •Pregnant or lactating women
- •Have been treated with capecitabine
- •Evidence of CNS metastasis
- •History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
- •Abnormal laboratory values: hemoglobin < 8.0 g/dl, neutrophils < 1.5×10^9/L, platelets < 100×10^9/L, serum creatinine > upper limit of normal (ULN), serum bilirubin > ULN, ALT and AST > 5×ULN, AKP > 5×ULN
- •Serious uncontrolled intercurrent infection
- •Life expectancy of less than 3 months
研究组 & 干预措施
A
Experimental
phase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer
干预措施: capecitabine and cyclophosphamide (Drug)
结局指标
主要结局
TTP (first treatment of this regimen to disease progression)
时间窗: every two cycles
次要结局
- side effects(all cycles)
- pharmacogenetic analysis(collect blood samples before this therapy)
研究者
研究点 (1)
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