An Multicenter, Randomized Study of Comparison of Docetaxel Plus Prednisone With Mitoxantrone Plus Prednisone in the Patients With Hormone-refractory (Androgen-independent) Metastatic Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Pain response (McGill-Melzack Scale)
研究概览
简要总结
To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and prednisone in subjects with hormone-refractory metastatic prostate cancer.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven prostate adenocarcinoma
- •Androgen independent prostate Cancer S/P orchiectomy and/or LHRH agonist Testosterone < 50 ng/dl (ie 1.735 nmol/l)
- •Documented progressive disease
- •Patients should have achieved stable analgesia for 7 days
- •Karnofsky Performance Status ≥ 70
- •No prior treatment with cytotoxic agent (except estramustine)
- •Normal cardiac function must be confirmed by Left ventricular ejection fraction
- •Adequate organ function:
- •Hematology:
- •Neutrophils > 1.5 x 10^9/L
- •Hemoglobin > 10 g/dl. Erythropoietin use is allowed, but red blood cell transfusion to upgrade the hemoglobin level is not allowed
- •Platelets > 100 x 10^9/L
- •Hepatic function:
- •Total bilirubin < the upper-normal limit of the institution.
- •Alanine aminotransferase and Aspartate transaminase < 1.5 times the upper-normal limit of the institution.
- •Renal function:
- •Creatinine < 1.5 times the upper normal limit (ie National Cancer Institution grade < 1)
- •No brain or leptomeningeal metastases
排除标准
- •Prior radiotherapy to >25% of bone marrow (whole pelvic irradiation is not allowed)
- •prior cytotoxic chemotherapy, except monotherapy with estramustine
- •prior isotope therapy
- •history of another cancer within the preceding five year
- •symptomatic peripheral neuropathy grade ≥ 2
- •other serious illness or medical condition:
- •Congestive heart failure even if controlled. Previous history of myocardial infarction or angina pectoris within 1 year from study entry, uncontrolled hypertension or uncontrolled arrhythmias.
- •Active uncontrolled infection
- •Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids.
- •Auto-immune disease (lupus, sclerodermia, rheumatoid polyarthritis)
- •treatment with any other anti-cancer therapy
- •treatment with bisphosphonates
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Docetaxel 75mg/m² intravenously (day 1) every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle
干预措施: Docetaxel (Drug)
1
Docetaxel 75mg/m² intravenously (day 1) every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle
干预措施: Prednisone (Drug)
2
Mitoxantrone 12mg/m² intravenously every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle
干预措施: Mitoxantrone (Drug)
2
Mitoxantrone 12mg/m² intravenously every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle
干预措施: Prednisone (Drug)
结局指标
主要结局
Pain response (McGill-Melzack Scale)
时间窗: From beginning to end of study
Efficacy: Overall survival
时间窗: From beginning to end of the study
Objective response rate of patients with measurable disease by Response Evaluation Criteria in Solid tumours
时间窗: From beginning to end of study
Prostatic Specific Antigen response
时间窗: From the beginning to the end of study
Time to progression
时间窗: From beginning to end of study
Adverse event
时间窗: From beginning to end of study
Quality Of Life: Functional assessment of chronic illness therapy-prostate questionnaire will be used
时间窗: From beginning to end of study
次要结局
未报告次要终点