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
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
- 否
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
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