Extravasation Clinical Trial
Official title:
A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
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
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.
Orphan drug status TopoTarget A/S was granted designation for Topotect® as an orphan medical
product for the treatment of anthracycline extravasations by the European Commission in
September 2001 and by the FDA in ???.
Purpose
Primary objectives:
• To prevent progression of the anthracycline extravasation lesion as tissue ulceration and
necrosis requiring surgical intervention
Secondary objectives:
- To prevent development of deep tissue necrosis and destruction leading to late sequelae
as impaired limb function and neurological deficit
- To prevent postponement of the scheduled cancer treatment due to the treatment of the
extravasation
- To evaluate the tolerance to and/or toxicity of Topotect® used for this indication,
according to the indicated schedule
Trial design This is an open-label, non-randomised phase II/III trial. Thirty -five
evaluable patients with anthracycline extravasations will be treated.
Extravasation is determined by the presence of pain, and/or swelling, and/or redness at the
site where anthracycline leakage is suspected to have occurred. The extravasations are
subsequently confirmed in each patient by fluorescence microscopy of at least two punch
biopsies at the time of the accident.
Success criteria The prevention of surgical intervention, necrosis and late sequelae
evaluated 3 months after the extravasation.
Safety features
- Toxicity caused by Topotect® will be examined by haematology and blood chemistry,
questions are asked on any discomfort. Scheduled clinical examinations are performed
- A systematic clinical evaluation of the marked area of skin covering the area of
extravasation will be performed in order to evaluate the need for surgery
- Sequential colour photographs of the involved skin will be taken
Medical Treatment Patients are treated with intravenous infusion of Topotect® administered
once daily on three consecutive days at the following doses: 1,000 mg/m2 + 1,000 mg/m2 + 500
mg/m2. The first dose is administered as soon as possible and within 6 hours of the
extravasation and the next two doses at 24 and 48 hours after the first infusion.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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