NCT00268710已完成2 期
Multicenter Phase II Study of Taxotere (Docetaxel) Administered Weekly or Every Three Weeks in Combination With Prednisone as Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer (HRPC)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 主要终点
- Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire)
研究概览
简要总结
Primary objectives:
- To determine the response rate, measurable and non measurable, to Taxotere® in the second line setting.
Secondary objectives:
- To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as second line therapy in HRPC
- To evaluate PSA response (PSA: Prostate Specific Antigen)
- To evaluate symptomatic response
- To evaluate Quality of life
- To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically proven prostate adenocarcinoma
- •Progression or non response with previous chemotherapy regimen (excluding Taxotere®)
- •Received previous mitoxantrone/prednisone or one other chemotherapy regimen including emcyt +/- vinblastine
- •Castration levels of testosterone (<50 ng/dL )
- •ECOG performance status 0-2
- •Laboratory requirements :
- •Hematology:
- •Neutrophils ≥ 1.5 x 10^9/L
- •Hemoglobin > 10 g/dL (prior transfusion permitted).
- •Platelets ≥ 100 x 10^9/L
- •Hepatic function:
- •Total bilirubin < the upper-normal limit of the institution.
- •ALAT (SGPT) and ASAT (SGOT) ≤ 1.5 times the upper-normal limit of the institution.
- •Renal function:
- •Creatinine ≤1.5 times the upper normal limit (i.e., NCI grade ≤1)
- •No severe or uncontrolled disease
排除标准
- •Chemotherapy within the last 4 weeks
- •Anti-androgen therapy within the last 4 weeks.
- •Prior malignancy except the following: adequately treated non-melanomatous skin cancer and superficial bladder cancer from which the patient has been disease-free for >2 years.
- •Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- •Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or OTC products for the treatment of prostate cancer must be stopped prior to study entry.
- •Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including active uncontrolled infection and significant cardiac dysfunction.
结局指标
主要结局
Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire)
时间窗: During the Study Conduct
次要结局
- Analgesics (assessed by Pain Medication Log)(During the study conduct)
- PSA (PSA response and PSA progression(During the study conduct)
- Tumor lesion assessment,(During the study conduct)
- Overall survival(During the study conduct)
- Progression-free survival(During the study conduct)
- Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry and clinical exams.(from the inform consent signed up to the end of the study)
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