NCT00166725已完成2 期
A Randomized, Open Label, Multicenter Study Evaluating the Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to 25% decrease in chromogranin A plasma level (evaluation every 4 weeks for the first 12 weeks and every 12 weeks after)
研究概览
简要总结
The present study will provide information on whether the somatostatin analog, octreotide acetate, could have an inhibitory effect on circulating chromogranin A. The demonstration of an antisecretory effect of somatostatin analogs could offer a rationale for a large scale randomized study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged >18
- •ECOG performance status < 3
- •Patients with metastatic prostate cancer currently receiving 1st line hormonal therapy (LHRH agonists or surgical castration) and failing with raising serum PSA
- •Biochemical progression documented by three consecutively rising serum PSA measurements, each separated from the other by at least 2 weeks, with the last measurement being 50% or greater than the nadir PSA achieved after the last therapeutic maneuver (i.e. first line hormonal therapy noted above)
- •Demonstrated tolerance to a test dose of s.c. octreotide acetate injection at Visit 1
- •Elevated (> 40 U/L according to DAKO Elisa kit) chromogranin A plasma levels documented by at least two consecutive measurements
- •Liver function tests < 2.5 ULN, serum creatinine within normality
- •Serum PSA (50% increased value) above 4 ng/mL for patients with intact prostate and > 0.8 ng/mL for post prostatectomy patients at study entry
- •Immediate history of rising PSA < 10 months
- •Castrate levels of testosterone (< 30 ng/dL)
- •Life expectancy of > 6 months
- •Signed informed consent prior to initiation of any procedure
排除标准
- •Prior chemotherapy or other systemic anticancer therapy except for LHRH agonists, and/or non-steroidal anti-androgens (eg, flutamide, bicalutamide or nilandron)
- •Palliative radiotherapy less than 6 weeks (42 days) prior to planned entry date
- •Other investigational drugs within the past 28 days
- •Long-term (> 3 months) treatment with proton pump inhibitors
- •Uncontrolled blood hypertension
- •Other malignancies within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer
- •Patients with another non-malignant disease which would confound the evaluation of the primary endpoints or prevent the patient from complying with the protocol
结局指标
主要结局
Time to 25% decrease in chromogranin A plasma level (evaluation every 4 weeks for the first 12 weeks and every 12 weeks after)
次要结局
- Change in circulating IGF-1, VEGF, IL-6, serum alkaline phosphatase, serum creatinine and serum calcium every 4 weeks for the first 12 weeks and every 12 weeks after
- PSA response (decrease > 50% or increase > 25% from baseline)
- Time to symptomatic progression (bone pain increase, deterioration of ECOG performance status)
研究者
研究点 (1)
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