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