A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Valerio Therapeutics
- Enrollment
- 57
- Locations
- 34
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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