Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Clinical feasibility of therapy administration
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, docetaxel,, paclitaxel, and ixabepilone work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paricalcitol may help chemotherapy drugs to kill more tumor cells by making tumor cells more sensitive to the drugs.
PURPOSE: This clinical trial is studying the best dose and best way to give paricalcitol and to see how well it works when given together with chemotherapy in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the ability to administer 8 continuous weeks of therapy within the first 3 months of enrollment with paricalcitol when given together with taxane or ixabepilone therapy in women with metastatic breast cancer.
- To estimate the proportion of patients who successfully complete 8 continuous weeks of therapy as well as the proportion of patients who achieve a 'steady-state' dose.
Secondary
- To determine a dose of paricalcitol that can be taken continuously that maintains a normal calcium level when combined with a taxane or ixabepilone.
- To determine if baseline levels of 25-hydroxycholecalciferol and parathyroid hormone (PTH) are associated with time to treatment failure in these patients.
- To determine if PTH levels decline from baseline in patients treated with paricalcitol in combination with taxane or ixabepilone therapy.
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
Paricalcitol (Zemplar)
Paricalcitol (Zemplar)
干预措施: docetaxel (Drug)
Paricalcitol (Zemplar)
Paricalcitol (Zemplar)
干预措施: ixabepilone (Drug)
Paricalcitol (Zemplar)
Paricalcitol (Zemplar)
干预措施: paclitaxel (Drug)
Paricalcitol (Zemplar)
Paricalcitol (Zemplar)
干预措施: paclitaxel albumin-stabilized nanoparticle formulation (Drug)
Paricalcitol (Zemplar)
Paricalcitol (Zemplar)
干预措施: paricalcitol (Drug)
结局指标
主要结局
Clinical feasibility of therapy administration
时间窗: Baseline to 8 weeks
To test the clinical/logistical feasibility of using a titrated dose of the vitamin D analog (paracalcitol or Zemplar) in combination with a taxane or ixabepilone primarily by measuring the proportion of patients who successfully complete 8 continuous weeks of therapy as well as the proportion of patients who achieve a 'steady-state' dose
次要结局
- Dose of paricalcitol that maintains a normal calcium level when given in combination with a taxane or ixabepilone(Baseline to 8 weeks)
- Correlation of baseline levels of 25-hydroxycholecalciferol and parathyroid hormone with time to treatment failure(Baseline to 8 weeks)
- Measurement of effect of combination of paricalcitol and a taxane or ixabepilone on parathyroid hormone levels failure(Baseline to 8 weeks)