NCT00705822终止3 期
Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Response rate over 50% in PSA
研究概览
简要总结
To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values.
To determine the time to treatment failure in both strategies To determine the overall and specific cause survival To evaluate the safety profile To analyze the Quality of Life
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmation of prostate adenocarcinoma
- •Advanced prostate carcinoma.
- •Previous treatment with hormones
- •Levels of testosterone < 50 ng/dL
- •Good hematological, liver and kidney function
- •Previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects.
排除标准
- •Previous chemotherapy (estramustine included).
- •Second line hormonotherapy (oestrogens, gestagens, ketoconazole, ...included)
- •Previous treatment with radiotherapy (isotopes) or previous radiotherapy over > 25% of the marrow
- •Any malignant process with a free disease interval under 5 years, exception done to non-melanoma skin cancer.
- •Concomitant serious diseases
- •Concomitant treatment with any other neoplassic therapy (exception done to LHRH agonists and/or biphosphonates).
- •Contraindication for the treatment with estramustine.
- •Previous history of pulmonary embolism, thromboembolic disease, previous treatment with anticoagulants (except aspirin), active thrombophlebitis or hypercoagulation.
- •Previous history of pulmonary spillage or ascitis.
- •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
Experimental
Docetaxel + Estramustine + Hydrocortisone
干预措施: Docetaxel + Estramustine + Hydrocortisone (Drug)
2
Active Comparator
Docetaxel + Prednisone
干预措施: Docetaxel + Prednisone (Drug)
结局指标
主要结局
Response rate over 50% in PSA
时间窗: every 3 weeks up to end of treatment and every month until PSA progression
次要结局
- Time to treatment failure(from Informed Consent signature up to end of the study)
- Time to progression(from Informed Consent signature up to study end)
- Overall and specific cause surveillance(from Informed Consent signature up to study end)
- Toxicity profile(from Informed Consent signature up to study end)
- Patients' Quality of Life(Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit)
研究者
研究点 (1)
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