A PHASE III STUDY OF THREE DIFFERENT DOSES OF SURAMIN (NSC #34936) ADMINISTERED WITH A FIXED DOSING SCHEDULE IN PATIENTS WITH ADVANCED PROSTATE CANCER
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 27
- 主要终点
- Response
研究概览
简要总结
Randomized phase III trial to compare the effectiveness of low, intermediate, and high dose suramin in treating men with stage IV prostate cancer that is refractory to hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of suramin is more effective for prostate cancer.
详细描述
OBJECTIVES:
I. Compare the response in patients with advanced hormone-refractory adenocarcinoma of the prostate treated with low- vs intermediate- vs high-dose suramin.
II. Compare the toxic effects of these regimens in these patients. III. Compare the overall and failure-free survival of patients treated with these regimens.
IV. Compare the duration of complete and partial responses in patients treated with these regimens.
V. Determine the population pharmacokinetics of these regimens and correlate these parameters with the toxicity of these regimens and response rate in these patients.
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 —（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
研究组 & 干预措施
Intermediate dose suramin
Intermediate dose suramin
干预措施: Suramin (Drug)
High dose suramin
High dose suramin
干预措施: Suramin (Drug)
Low dose suramin
Low dose suramin
干预措施: Suramin (Drug)
结局指标
主要结局
Response
时间窗: Week 12 and every 12 weeks thereafter
Radiographic evaluation
次要结局
- Toxicity(pre-study, day 1, then every 2 weeks during treatment and every 8 weeks during follow up)
- Survival(post treatment until patient expires)
- Quality of Life(pre-study, 2 weeks post treatment, and every 12 weeks in follow up)