Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Objective Response Rate by RECIST Criteria Following
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine hydrochloride together with genistein works in treating women with stage IV breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in patients with stage IV breast cancer treated with gemcitabine hydrochloride and genistein.
Secondary
- Determine the duration of response and survival of patients treated with this regimen.
- Determine the time to disease progression in patients treated with this regimen.
- Determine the quantitative and qualitative toxic effects of this regimen in these patients.
- Correlate plasma genistein levels with response in patients treated with this regimen.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gemcitabine, genistein (Novasoy), Tumor biopsy
Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
干预措施: genistein (Dietary Supplement)
Gemcitabine, genistein (Novasoy), Tumor biopsy
Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
干预措施: gemcitabine (Drug)
Gemcitabine, genistein (Novasoy), Tumor biopsy
Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
干预措施: Tumor biopsy (Procedure)
结局指标
主要结局
Objective Response Rate by RECIST Criteria Following
时间窗: every 2 courses until disease progression or death, up to 24 weeks
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
未报告次要终点
研究者
Lawrence E. Flaherty
Investigator
Barbara Ann Karmanos Cancer Institute