跳至主要内容
临床试验/NCT00158379
NCT00158379已完成2 期

Carboplatin With Following Taxol® Therapy Under Additional Application of Epoetin Alfa (ERYPO ®) With Female Patients With Advanced Ovarian Cancer FIGO IA/G3 - IV

North Eastern German Society of Gynaecological Oncology0 个研究点目标入组 105 人开始时间: 2003年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
105
主要终点
Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%

研究概览

简要总结

Time to progression (physical examination and radiologic imaging

研究设计

研究类型
Interventional
分配方式
Na
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
Female
接受健康志愿者

入选标准

  • patients with primary ovarian cancer
  • ECOG- 0-2
  • Age >= 18
  • no chemotherapy, radiation or immunotherapy in medical history for ovarian cancer
  • adequate bone marrow, liver and kidney reserve: leukocytes ≥ 2.0 x 109/l, platelets ≥ 100 x 109/l, bilirubin <= 2,0 mg%, creatinine <= 1,5 mg% or creatinine clearance ≥ 60 ml/ min, hemoglobin ≥ 9 g/ dl SGOT, SGPT an AP within 3 fold of the reference laboratory's normal range
  • written informed consent

排除标准

  • before-existing heart illness, Cardiac infarct within last 6 months
  • Radiotherapy within 4 weeks for study entry
  • Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intrauterine devices, surgical methods of sterilization, or, in hormone insensitive tumors only, oral, subcutaneous or transvaginal hormonal, non-estrogen containing contraceptives)

研究组 & 干预措施

Paclitaxel

Experimental

干预措施: Paclitaxel (Drug)

结局指标

主要结局

Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%

时间窗: every 3 months for up to 3 years

Time to progression

次要结局

  • Toxicity(after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years)

研究者

申办方类型
Other
责任方
Sponsor

相似试验