Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 770
- 试验地点
- 16
- 主要终点
- Compare overall survival in the two study arms
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether estramustine plus docetaxel is more effective than mitoxantrone plus prednisone for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of estramustine plus docetaxel with that of mitoxantrone plus prednisone in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES:
- Compare the overall survival and progression-free survival in patients with hormone-refractory, metastatic adenocarcinoma of the prostate treated with docetaxel and estramustine vs mitoxantrone and prednisone.
- Compare the qualitative and quantitative toxic effects of these regimens in this patient population.
- Compare the quality of life, including palliation of metastatic bone pain and global quality of life, of patients treated with these regimens.
- Record prostate-specific antigen values for future correlations with response and survival in patients treated with these regimens.
- Compare the responses in patients with bidimensionally measurable disease treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (measurable or evaluable disease progression vs rising PSA only), NCI Common Toxicity Criteria version 2.X pain scale (grade 2 or greater vs less than 2), and SWOG performance status (0-1 vs 2-3). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2.
- Arm II: Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21.
Treatment in both arms repeats every 3 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.
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
Docetaxel and Estramustine
Estramustine, 280 mg, PO, TID, Days 1-5; q 21 days Docetaxel, 60mg/m2, IV, Day 2; q 21 days
干预措施: docetaxel (Drug)
Docetaxel and Estramustine
Estramustine, 280 mg, PO, TID, Days 1-5; q 21 days Docetaxel, 60mg/m2, IV, Day 2; q 21 days
干预措施: estramustine (Drug)
Mitoxantrone and Prednisone
Mitoxantrone, 12 mg/m2, IV, Day 1; q 21 days Prednisone, 5 mg, PO, BID, Days 1-21; q 21 days
干预措施: mitoxantrone (Drug)
Mitoxantrone and Prednisone
Mitoxantrone, 12 mg/m2, IV, Day 1; q 21 days Prednisone, 5 mg, PO, BID, Days 1-21; q 21 days
干预措施: prednisone (Drug)
结局指标
主要结局
Compare overall survival in the two study arms
时间窗: up to 4 years
Measured from date of registration to date of death due to any cause
次要结局
- Compare progression-free survival between two study arms(up to 4 years)
- Compare Prostate-Specific Antigen (PSA) response between two study arms(up to 4 years or time of disease progression)
- Compare objective responses between two study arms(up to 12 cycles of treatment ( 1cycle = 21 days))
- Compare toxicities between the two study arms(up to 12 cycles of treatment (1 cycle = 21 days))