跳至主要内容
临床试验/NCT00189371
NCT00189371终止3 期

Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum

AGO Study Group1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2004年2月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
终止
发起方
入组人数
300
试验地点
1
主要终点
Reduction of anemia

研究概览

简要总结

Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Relapse more than 6 months following first line chemotherapy is regarded as platinum/taxane sensitive disease. Reinduction chemotherapy with platinum/taxane is known to be an effective treatment option. Therapy induced anemia is a common problem resulting in decrease of quality of life. The rationale of this trail is to evaluate the effects of epoetin alpha on reduction of therapy induced anemia, rate of transfusions and on quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • •Relapse longer than 6 months after termination of platinum/taxane based first line chemotherapy
  • •Previously histologically confirmed cancer of: ovary, fallopian tube, peritoneum
  • •measurable and evaluable lesions by ultrasound, computer-tomography or MRI
  • •Performance status ECOG < 2 or karnofsky index > 60%
  • •normal organ function

排除标准

  • •more than 1 chemotherapy prior enrollment
  • •ongoing treatment with epoetin alpha or related drugs
  • •history of thrombosis or embolism during the past 12 months prior enrollment
  • •left ventricular failure > NYHA classification > 2
  • •Ongoing toxicity of any kind (> CTC Grad II)

结局指标

主要结局

Reduction of anemia

次要结局

  • Quality of life
  • Overall survival
  • Progression free survival
  • Toxicity

研究者

发起方
AGO Study Group
申办方类型
Other

研究点 (1)

Loading locations...

相似试验