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临床试验/NCT00193193
NCT00193193已完成2 期

A Randomized, Phase II Trial of Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin Administered Either Weekly or Every Four Weeks in the Treatment of Hormone Refractory Prostate Carcinoma

SCRI Development Innovations, LLC0 个研究点目标入组 100 人开始时间: 2000年8月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
主要终点
Overall response rate

研究概览

简要总结

In this trial we will investigate how this three-drug regimen may be improved, both with respect to efficacy and toxicity, by making some modifications in the dosing and schedule in the treatment of patients with hormone refractory prostate cancer.

详细描述

Upon determination of eligibility, patients will receive:

Paclitaxel + Estramustine + Carboplatin

Patients will receive weekly paclitaxel and low-dose estramustine, in combination with carboplatin administered either weekly r every four weeks.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adenocarcinoma of the prostate not curable with local treatment
  • Disease progression while receiving hormonal therapy
  • Measurable or evaluable disease
  • Previous treatment with a maximum of one prior chemotherapy regimen
  • ECOG performance status 0, 1, or
  • Adequate bone marrow, liver and kidney function
  • Able to comprehend the nature of this study and give written informed consent

排除标准

  • You cannot participate in this study if any of the following apply to you:
  • Age < 18 years
  • History of treatment for an invasive malignancy within five years
  • Significant heart disease
  • Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

结局指标

主要结局

Overall response rate

次要结局

  • Toxicity
  • Overall survival

研究者

申办方类型
Other

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