NCT00634582终止2 期
Phase II Trial of Zemplar (19-nor-1 a,25-Dihydroxyvitamin D2, Paricalcitol Capsule) on Bony Remodeling in Advanced Androgen-Insensitive Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Biochemical Markers (i.e., Serum Parathyroid Hormone [PTH], Bone-specific Alkaline Phosphatase, and Osteocalcin) That Are Surrogates for Fracture Risk and Are Associated With Increased Bone Pain, Morbidity, and Mortality From Prostate Cancer
研究概览
简要总结
RATIONALE: Paricalcitol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. It may also stop the growth of tumor cells in bone.
PURPOSE: This phase II trial is studying how well paricalcitol works in treating patients with advanced prostate cancer and bone metastases.
详细描述
OBJECTIVES:
Primary
- To explore the relationship between paricalcitol therapy and markers of bone formation in patients with androgen-refractory, advanced prostate cancer with bone metastases.
Secondary
- To explore the relationship between paricalcitol therapy and markers of bone resorption in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed advanced adenocarcinoma of the prostate
- •- Radiographically proven bone metastasis from prostate cancer
- •Androgen refractory disease (including anti-androgen withdrawal)
- •Secondary hyperparathyroidism, defined as two parathyroid hormone (PTH) values > 70 pg/mL, 14 days apart
- •ECOG performance status 0-2
- •Leukocytes ≥ 3,000/μL
- •Absolute neutrophil count ≥ 1,500/μL
- •Platelets ≥ 100,000/μL
- •Total bilirubin normal
- •AST/ALT ≤ 2.5 times upper limit of normal
- •Creatinine clearance ≥ 60 mL/min
- •Calcium normal
- •25-hydroxyvitamin D (25-OHD) ≥ 20 ng/mL
- •1,25(OH)_2D normal
- •Patients with serum 25-OHD indicative of vitamin D insufficiency are eligible provided they are treated with ergocalciferol to raise 25-OHD levels to 20 ng/mL prior to paricalcitol therapy
- •More than 8 weeks since prior bisphosphonates
- •More than 2 weeks since prior palliative radiotherapy
- •More than 4 weeks since other prior therapy
- •No more than one prior taxane-containing chemotherapy regimen for metastatic disease
- •Multiple lines of prior therapy with hormonal agents allowed
- •Concurrent corticosteroids allowed provided the dose remains stable during the study period
排除标准
- •Underlying metabolic bone disease or vitamin D deficiency
- •History of hypercalcemia
- •Concurrent uncontrolled illness or co-morbid condition (including psychiatric illness) that would interfere with study compliance
- •Concurrent ergocalciferol supplementation
- •Concurrent chemotherapy or hormonal therapy
- •Concurrent investigational or commercial agents for the malignancy
结局指标
主要结局
Biochemical Markers (i.e., Serum Parathyroid Hormone [PTH], Bone-specific Alkaline Phosphatase, and Osteocalcin) That Are Surrogates for Fracture Risk and Are Associated With Increased Bone Pain, Morbidity, and Mortality From Prostate Cancer
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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