A Phase II Trial of Capecitabine and Oxaliplatin (CAPOX) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE03-60
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- - To determine the objective response rate (CR+PR) of capecitabine and oxaliplatin (CAPOX) in patients with metastatic breast cancer.
研究概览
简要总结
In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to surrounding normal tissue. This trial will investigate the activity of this novel capecitabine/oxaliplatin (CAPOX) combination in patients with advanced disease. In addition, an exploratory analysis will correlate response with thymidine synthase and thymidine phosphorylase expression in primary tumor samples.
详细描述
OUTLINE: This is a multi-center study.
CAPOX (21 day cycle):
- Capecitabine 825 mg/m2 orally twice daily Days 1-14.
- Oxaliplatin 100 mg/m2 intravenously Day 1
Patients may continue combination therapy until progression or toxicity intervenes. Patients who discontinue either agent due to toxicity may, at the investigators discretion, continue therapy with the remaining single agent on study.
ECOG performance status 0 or 1
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologic or cytologic diagnosis of breast cancer with evidence of (1) unresectable, locally recurrent, or (2) metastatic disease.·
- •Patients with HER2 positive (3+ overexpression by IHC or gene amplification by FISH) are eligible only if they have had prior trastuzumab therapy.·
- •At least one measurable lesion as defined by the RECIST.
- •Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
排除标准
- •No prior therapy with capecitabine or oxaliplatin in any setting
- •No prior therapy with other platinum compounds·
- •No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to beginning protocol therapy.·
- •No prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.·
- •No prior fluoropyrimidine therapy for metastatic disease is allowed. Prior adjuvant fluoropyrimidine therapy is allowed if completed > 12 months from study entry.·
- •Maximum of one prior chemotherapy regimen for unresectable, locally recurrent or metastatic disease·
- •No symptomatic brain metastasis. ·
- •No evidence of serious concomitant systemic disorders incompatible with the study ·
- •No peripheral neuropathy ·
- •No major surgery within 28 days prior to beginning protocol therapy.·
- •Negative pregnancy test·
- •No female patients currently breastfeeding·
- •No malabsorption syndrome·
- •No evidence of serious concomitant systemic disorders incompatible with the study·
- •Patients must not be treated with any of the following while on protocol therapy or within 28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine, allopurinol.
研究组 & 干预措施
Single Group Assignment
Capecitabine + Oxaliplatin
干预措施: Capecitabine (Drug)
Single Group Assignment
Capecitabine + Oxaliplatin
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
- To determine the objective response rate (CR+PR) of capecitabine and oxaliplatin (CAPOX) in patients with metastatic breast cancer.
时间窗: 36 months
次要结局
- To determine rate of clinical benefit response (CR + PR + SD > 6 months). ·(36 months)
- To explore potential correlations between thymidine synthase (TS), thymidine phosphorylase (TP) and dihydropyrimidine dehydrogenase (DPD) expression in the primary tumor with response.(36 months)
- To measure time to progression ·(36 months)
- To determine toxicity rate of CAPOX in this patient population.·(36 months)
研究者
Kathy Miller, MD
Professor, IU School of Medicine
Hoosier Cancer Research Network