Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 主要终点
- Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.
详细描述
This observational program is aimed at gaining tolerability and safety data with the routine use of Caelyx in its labelled indication in ovarian cancer, focusing on infusion reaction and PPE.
Data will be raised about the premedication routinely used for the prevention of side effects caused by Caelyx. Premedications for infusion reactions include corticosteroids, serotonin 3 (5HT3) antagonists, histamine 1 (H1) blockers, and histamine 2 (H2) blockers. Premedications for PPE include oral dexamethasone and vitamin B6.
The management of infusion reactions and PPE will be recorded. A detailed record of the medical history may reveal patient groups at a higher risk of experiencing these side effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with advanced ovarian cancer with:
- •previous platin/taxane therapy and documented measureable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.
排除标准
- •Patients that are not treated according to the Austrian Summary of Product Characteristics (SPC)
研究组 & 干预措施
1
Women with advanced ovarian cancer
干预措施: Caelyx (Pegylated Lyposomal Doxorubicin) (Drug)
结局指标
主要结局
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)
时间窗: The observational program was conducted over a period of 2 years
Definitions in assessment of adverse event severity: Mild: awareness of sign, symptom, or event, but easily tolerated. Moderate: discomfort enough to cause interference with usual activity and may warrant intervention. Severe: incapacitating with inability to do usual activities or significantly affects clinical status, and warrants intervention.
次要结局
未报告次要终点