NCT00627354已完成2 期
Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer
Groupe D'Etude des Tumeurs Uro-Genitales2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2006年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Palliative response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, etoposide, and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which drug is more effective in killing tumor cells.
PURPOSE: This randomized phase II trial is studying how well mitoxantrone works compared to etoposide or vinorelbine works as second-line therapy in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
详细描述
OBJECTIVES:
Primary
- Determine the palliative response rate in patients with hormone-resistant prostate cancer treated with mitoxantrone hydrochloride vs etoposide vs vinorelbine ditartrate as second-line therapy.
Secondary
- Determine the duration of palliative response in patients treated with these regimens.
- Determine the biological response (PSA > 50%) in these patients.
- Determine the time to progression (biological and clinical) in these patients.
- Determine the overall survival of these patients.
- Determine the quality of life and the impact on autonomy of patients over 70 years of age.
- Determine the toxicity of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Metastatic progressive disease meeting the following criteria:
- •Increase in measurable lesions > 25%
- •Increase in bone lesions > 25%
- •Biological progression rate of PSA > 4 ng/mL
- •Received docetaxel as first-line chemotherapy
- •Received at least 1 prior regimen of hormone therapy
- •Pain > 2 on Visual Analog Scale or continuing level 2 analgesics
- •No symptomatic or evolutionary CNS disease
- •PATIENT CHARACTERISTICS:
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine ≤ 1.5 times normal
- •Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present)
- •Transaminases ≤ 1.5 times normal
- •Bilirubin ≤ 1.5 times normal
- •No prior malignancy except basal cell skin cancer
- •No peripheral neuropathy or severe neuropathy ≥ grade 2
- •No other severe lung, hepatic, renal, or digestive disease that would be complicated by treatment
- •LVEF > 50%
- •No history of peptic ulcer, unstable diabetes, or other contraindication to using steroids
- •No severe infection requiring antibiotics
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 8 weeks since prior metabolic radiotherapy
- •More than 4 weeks since prior external radiotherapy
- •At least 1 month since prior docetaxel-based chemotherapy
- •At least 1 month since prior antiandrogen therapy in the case of complete hormonal blockage
- •No participation in another clinical trial within the past 30 days
排除标准
- 未提供
结局指标
主要结局
Palliative response rate
次要结局
- Duration of palliative response
- Biological response
- Tumor response as assessed by RECIST criteria
- Time to progression
- Overall survival
- Quality of life as assessed by QLQ-PR25
- Impact on autonomy in patients > 70 years of age
- Toxicity
研究者
研究点 (2)
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