Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer
Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer
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.
研究概览
详细说明
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.
OUTLINE: Beginning on day 1, patients receive oral paricalcitol. The dose of paricalcitol is increased every 2 weeks until the serum calcium level is between 9 mg/dL and 11.4 mg/dL. Once this level is reached, the patient continues at that dose for the duration of the study. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation, docetaxel, or paclitaxel once a week or once every 3 weeks or ixabepilone once every 3 weeks. Treatment continues for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27157-1096
- Wake Forest University Comprehensive Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
Histologically confirmed invasive breast cancer
- Metastatic or recurrent disease
- Patients with bone metastasis only are eligible and evaluable for time to progression
- Candidate for taxane or ixabepilone therapy
- At least one lesion that can be measured in at least one diameter ≥ 2 cm by CT scan
- No symptomatic brain metastases or other symptomatic CNS metastases
- ECOG performance status 0 or 1
- Life expectancy > 3 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 2.0 g/dL
- Albumin corrected serum calcium < 10.5 mg/dL
- Fertile patients must use effective contraception during and for at least 1 year after study participation
- At least 2 weeks since prior chemotherapy or radiation therapy
- Prior and concurrent taxane or ixabepilone therapy allowed
- Concurrent oral multivitamins allowed (i.e., Centrum or One a Day)
- Concurrent bisphosphonates allowed
Exclusion Criteria
- History of allergy to calcitriol, paricalcitol, or other Vitamin D compounds
- History of drug or alcohol abuse within the past 6 months
- History of other malignancy except inactive nonmelanoma skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or other cancer if the patient has been disease-free for 5 or more years
- Serious medical illness that would limit survival to < 3 months
- Active, uncontrolled bacterial, viral or fungal infection
- Poorly controlled diabetes
- Concurrent supplemental calcium
- Concurrent digitalis compounds
- Concurrent chemotherapy
- Concurrent biologic therapy, including trastuzumab and bevacizumab
- Concurrent hormonal agents for breast cancer except luteinizing hormone-releasing hormone agonists
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Paricalcitol (Zemplar)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical feasibility of therapy administration
大体时间：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
|
Baseline to 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dose of paricalcitol that maintains a normal calcium level when given in combination with a taxane or ixabepilone
大体时间：Baseline to 8 weeks
|
Baseline to 8 weeks
|
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Correlation of baseline levels of 25-hydroxycholecalciferol and parathyroid hormone with time to treatment failure
大体时间：Baseline to 8 weeks
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To determine if baseline levels of 25(OH)D and parathyroid hormone are associated with time to treatment failure in patients treated with the combination of paricalcitol and a taxane or ixabepilone
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Baseline to 8 weeks
|
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Measurement of effect of combination of paricalcitol and a taxane or ixabepilone on parathyroid hormone levels failure
大体时间：Baseline to 8 weeks
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To determine if parathyroid hormone levels decline from baseline with the combination of paricalcitol and a taxane or ixabepilone
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Baseline to 8 weeks
|
合作者和调查者
调查人员
- 学习椅：Julia A. Lawrence、Wake Forest University Health Sciences
- 首席研究员：Susan A. Melin, MD、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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