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临床试验/EUCTR2004-003885-14-ES
EUCTR2004-003885-14-ES进行中(未招募)1 期

Multidisciplinar, multicenter, randomized phase III clinical trial comparing taxotere plus estramustine phosphate plus prednisone, versus taxotere prednisone, in advanced prostate carcinoma patients with biochemical relapse during androgen ablation.

Aventis Pharma, S.A.0 个研究点目标入组 172 人开始时间: 2006年1月23日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
172

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • - Histologically confirmed prostate adenocarcinoma
  • - Confirmed prostate adenocarcinoma in biochemistry progression androgens block and demonstrated progression despite cessation of antiandrogen therapy.
  • - Patients must have received prior hormonal therapy.
  • - Castration levels of testosterone (Minor to 50 ng/dL)
  • - Biochemistry relapse.
  • - Adequate bone marrow, Hepatic and Renal function.
  • - Patients must be accessible for treatment and follow-up.
  • - Prior surgery and/or radiation therapy is allowed if at least 4 weeks have elapsed since the completion of radiation therapy and the patient have recovered from side effects.
  • Are the trial subjects under 18?
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years)
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Prior cytotoxic chemotherapy (including AMP, Ketoconazole), radio isotopes or other hormonal therapy.
  • - Prior malignancy except any cancer adequately treated from wich the patient has been disease free for 2 years or more.
  • - Symptomatic peripheral neuropathy grade mayor or equal to 2 according to NCIC-CTG criteria.
  • - Concomitant serious illness or medical condition:
  • a) Uncontrolled or severe cardiovascular disease.
  • b) Active uncontrolled infection.
  • c) Active peptic ulcer.
  • d) Unstable diabetes mellitus.
  • - Previous history of tromboembolic events in the last 6 months or active thrombophlebitis.
  • - Medical contraindication for EMP including history to estradiol or nitrogen mustard.

研究者

发起方
Aventis Pharma, S.A.

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