NCT00238199已完成2 期
Phase II Study of Calcitriol-Enhanced Docetaxel in Patients With Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Time to progression
研究概览
简要总结
RATIONALE: Calcitriol may cause pancreatic cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may also help docetaxel work better by making the tumor cells more sensitive to the drug. Giving calcitriol together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving calcitriol together with docetaxel works in treating patients with metastatic or locally advanced pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the time to progression in patients with metastatic or locally advanced pancreatic cancer treated with calcitriol and docetaxel.
Secondary
- Determine the median and one-year survival of patients treated with this regimen.
- Determine the overall response in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the change in pancreatic cancer-induced pain 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of pancreatic cancer
- •Locally advanced or metastatic disease
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •Life expectancy
- •Not specified
- •Hematopoietic
- •White blood cell (WBC) > 3,000/mm^3
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase (AP) < 5.0 times ULN
- •Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 2.5 times ULN (if AP < 2.5 times ULN) OR
- •ALT and AST < 1.5 times ULN (if AP > 2.5 times ULN and < 5.0 times ULN)
- •Creatinine < 1.3 mg/dL
- •Calcium < 10.5 mg/dL
- •Phosphate < 4.7 mg/dL
- •No kidney stones within the past 5 years
- •No history of hypercalcemia
- •Cardiovascular
- •No myocardial infarction within the past 3 months
- •No uncontrolled heart failure with a known ejection fraction < 30%
- •No other significant heart disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
- •No peripheral neuropathy ≥ grade 2
- •No comorbid condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for metastatic disease
- •No prior chemoradiotherapy for locally advanced disease
- •No prior adjuvant docetaxel
- •Other prior adjuvant chemotherapy allowed
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Chemotherapy
- •More than 2 weeks since prior radiotherapy
- •More than 30 days since prior investigational surgery
- •More than 7 days since prior and no concurrent digoxin or thiazide diuretic therapy
- •More than 30 days since prior investigational therapy
- •No concurrent magnesium-containing antacids, bile resin-binding drugs, or calcium supplements
排除标准
- 未提供
结局指标
主要结局
Time to progression
次要结局
- Median and one-year survival
- Toxicity
- Overall response
- Change in pancreatic cancer-induced pain
研究者
研究点 (2)
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