A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 67
研究概览
简要总结
The purpose of this study is
- To prevent progression of a lesion caused by anthracycline extravasation into necrosis, which would require surgical intervention
- To prevent development of deep tissue necrosis and destruction leading to impaired limb function and neurological deficit
- To prevent postponement of the scheduled cancer treatment due to the treatment of the extravasation
详细描述
Accidental extravasation of anthracyclines, e.g. doxorubicin and its derivative epirubicin, may cause progressive tissue destruction including serious damage of the skin, the subcutaneous tissue, muscles, and nerves.
The patient may suffer from acute local symptoms such as pain and swelling, which may progress into blistering and necrosis. Subsequently dysesthesia, skin atrophy, disfigurement, and impaired limb function may be the consequence.
Surgical removal of all affected tissue is required and the debridement often necessitates split skin grafting. The patient is thus subjected to the distress of major surgery, which in turn leads to delay of further cytotoxic treatment.
Preclinical animal studies as well as a clinical multicenter phase II trial have demonstrated a highly significant efficacy of dexrazoxane in preventing tissue destruction caused by anthracyclines.
This confirmatory trial will determine the effect of Topotect® (dexrazoxane) as an acute antidote in patients with anthracycline extravasation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •All cancer patients treated with anthracyclines
- •Informed consent must be obtained from the patient
- •Patients suspected to have been exposed to extravasation (leakage) of anthracycline, defined as:
- •A primary assessment by the physician on duty, which would activate the standard departmental procedure for treatment of anthracycline extravasation.
- •The presence of at least one of the following symptoms: pain, swelling or redness at the site where the anthracycline leakage is suspected to have occurred.
- •Suspicion of anthracycline extravasation from a central venous access device
- •The Topotect® infusion must be started < 6 hours after the accident
- •18 years of age or older
- •Performance status (PS) < 2
排除标准
- •Known allergy towards dexrazoxane
- •Reasonable suspicion of extravasation by other compounds than anthracyclines through the same intravenous access, e.g. vincristine, mitomycin, and vinorelbine, all of which may cause ulceration
- •AST (aspartate aminotransferase) or ALT (alanine aminotransferase), bilirubin, LDH (lactate dehydrogenase), alkaline phosphatase >3 x upper normal value
- •Neutrophils CTC (common toxicity criteria) ≥ grade
- •(neutrophils 1.5 x 109/L, ≥1,500/mm3)
- •Platelets CTC ≥ grade
- •(platelets ≥75.0 x 109/L, <75,000/mm3).
- •Topical use of DMSO (dimethylsulfoxide) at the area of the accident
- •Administration of dexrazoxane within the last 3 weeks
- •Pregnant or nursing women
- •Women of childbearing age and potential, who do not use an efficient contraceptive (e.g. the Pill or a diaphragm plus a spermicide) for at least 3 months prior to the start of trial medication