A Phase II Study of Estramustine, Docetaxel, and Carboplatin With G-CSF Support in Men With Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES: I. Determine the response rate (objective and PSA response) and duration of response to estramustine, docetaxel, and carboplatin with filgrastim (G-CSF) support in patients with hormone refractory prostate cancer. II. Determine the toxicity of this regimen in this patient population.
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
- 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
Estramustine + docetaxel + carboplatin+ filgrastim
Patients receive oral estramustine 3 times daily on days 1-5. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 1 hour on day 2. Filgrastim (G-CSF) SC is administered beginning on day 6 and continuing until hematopoietic recovery. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for a maximum of 2 years.
干预措施: filgrastim (Biological)
Estramustine + docetaxel + carboplatin+ filgrastim
Patients receive oral estramustine 3 times daily on days 1-5. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 1 hour on day 2. Filgrastim (G-CSF) SC is administered beginning on day 6 and continuing until hematopoietic recovery. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for a maximum of 2 years.
干预措施: carboplatin (Drug)
Estramustine + docetaxel + carboplatin+ filgrastim
Patients receive oral estramustine 3 times daily on days 1-5. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 1 hour on day 2. Filgrastim (G-CSF) SC is administered beginning on day 6 and continuing until hematopoietic recovery. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for a maximum of 2 years.
干预措施: docetaxel (Drug)
Estramustine + docetaxel + carboplatin+ filgrastim
Patients receive oral estramustine 3 times daily on days 1-5. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 1 hour on day 2. Filgrastim (G-CSF) SC is administered beginning on day 6 and continuing until hematopoietic recovery. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for a maximum of 2 years.
干预措施: estramustine phosphate sodium (Drug)
结局指标
主要结局
Response rate
时间窗: Up to 2 years
次要结局
未报告次要终点