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临床试验/RPCEC00000248
RPCEC00000248已完成2 期

ew therapeutic regimen for patients with hormone-resistant prostate cancer: Phase II-III clinical trial using the anti-inflammatory with the highest anti-tumor effect in pre-clinical trials (meclo/mefenamate) combined with standard treatment (Docetaxel) - MEFEPROST

Medical School of the University of Colima, Mexico0 个研究点目标入组 40 人开始时间: 2017年8月15日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment

入排标准

年龄范围
40 years 至 one(—)
性别
Male

入选标准

  • 1. Clinical and histological diagnosis of castration-resistant prostate cancer.
  • 2. That the treating oncologist considers that the administration of Docetaxel is the feasible and appropriate treatment for the patient (for control group 1 and experimental group 1).
  • 3. Functional status ECOG 0 to 2.
  • 4 Patients with no history of hepatic impairment or renal impairment (creatinine clearance should be greater than 60 milliliters / minute).
  • 5. Sign written informed consent of the patient.

排除标准

  • 1. ECOG 3 or greater
  • 2. Diagnosis of second primary cancer.
  • 3. Patients with uncontrolled arterial hypertension
  • 4. Creatinine clearance less than 60 milliliters per minute
  • 5. Leukocytes less than 3000 cells / microliter or platelet count less than 100,000 cells / microliter 6. Leukocytes greater than 10,000 cells / microliter or showing data Of systemic infection
  • 7. Blood hemoglobin less than 9gr / deciliter 8. Alcoholism and / or drug addiction
  • 9. Gastrointestinal ulcer
  • 10. Inflammatory bowel disease
  • 11. Diagnosis of ischemic heart disease
  • 12. Other pathologies at the discretion of the investigator.

研究者

发起方
Medical School of the University of Colima, Mexico

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