NCT00182741已完成2 期
Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
研究概览
简要总结
RATIONALE: Calcitriol may cause prostate cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well giving calcitriol together with mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.
详细描述
OBJECTIVES:
Primary
- Determine the prostate-specific antigen (PSA) response rate, defined as the fraction of patients with 50% reduction in PSA level over 3 weeks' time, in patients with androgen-independent metastatic prostate cancer treated with high-dose pulse calcitriol, mitoxantrone, and prednisone.
Secondary
- Determine the safety and tolerability of this regimen in these patients.
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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
次要结局
- Toxicity as measured by Common Toxicity Criteria v3.0
- Confirmed PSA reduction > 75% measured every 21 days
- Time to palliative-progression as measured by McGill-Melzack Pain Questionnaire every 21 days
- Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days
- PSA normalization (< 4 ng/mL) measured every 21 days
- Response to measurable disease as measured by RECIST criteria every 9 weeks
- Analgesic response as measured by McGill-Melzack Pain Questionnaire every 21 days
- Analgesic medication use decreased by ≥ 50% without an increase in pain for 2 consecutive evaluations at least 3 weeks apart
- Palliative response as measured by McGill-Melzack Pain Questionnaire every 21 days
- Quality of life as measured by EORTC core questionnaire Quality of Life-C30 every 21 days
- Time to PSA progression measured every 21 days
- Time to progression in measurable or evaluable disease as measured by whole body scan and/or CT or MRI scan every 9-12 weeks
- Time to death assessed every 6 months after completion of study treatment
研究者
Christopher Ryan
Principal Investigator
OHSU Knight Cancer Institute
研究点 (2)
Loading locations...
相似试验
终止
2 期
Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone TherapyProstate CancerNCT00524589Roswell Park Cancer Institute18
已完成
1 期
Calcitriol and Zoledronate in Treating Patients With Progressive Prostate CancerProstate CancerNCT00004928Memorial Sloan Kettering Cancer Center
已完成
1 期
Calcitriol, Ketoconazole, and Dexamethasone in Treating Patients With Metastatic or Unresectable Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00238225Roswell Park Cancer Institute15
已完成
2 期
Calcitriol in Treating Patients With a Rising PSA Level Following Treatment for Prostate CancerProstate CancerNCT00004043OHSU Knight Cancer Institute25
已完成
2 期
Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic CancerPancreatic CancerNCT00238199OHSU Knight Cancer Institute25