A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
18 Years
N/A
Both
Anthracycline Extravasation
Trial Information
A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Accidental extravasation of anthracyclines including doxorubicin and its derivative
epirubicin, may cause severe, progressive tissue necrosis requiring the surgical removal of
any damaged tissue. Thus, the patient is subjected to major surgery causing substantial
delay of the treatment of the primary cancer disease.
Tissue infiltration by anthracyclines may be detected by fluorescence microscopy. This test
is performed at most hospitals in Denmark.
In a large preclinical trial, as well as 4 clinical cases, dexrazoxane has proven to prevent
these severe tissue necroses. This trial will determine the effect of dexrazoxane as an
acute treatment (acute antidote) in patients with anthracycline extravasation verified by
fluorescence biopsy.
Purpose
Primary:
• To avoid surgical intervention following the accidental extravasation of anthracycline
drug, and thus preventing the patient from sequelae.
Secondary:
- To avoid deleterious postponement of the cancer treatment itself.
- To evaluate and describe subjective and objective symptoms in the damaged area
following treatment with TopotectTM.
- To evaluate tolerability/toxicity of TopotectTM used for this indication, according to
the indicated schedule.
Trial Population 25 patients with accidental anthracycline extravasation confirmed by
fluorescence microscopy
Trial Design Open-label clinical trial. Twenty-five consecutive patients with an acute (<6
hours) history of anthracycline extravasation confirmed by fluorescence microscopy (who in
general practice are candidates for acute plastic surgical intervention) will be included.
Effect Variables Response rates, presence of late sequelae, time to progression, and
clinical consequence of progression.
Safety Features
- Any toxicity caused by TopotectTM will be studied by blood tests, systematic
questioning regarding subjective discomfort, as well as by objective clinical
examination.
- A systematic clinical evaluation of the marked area of skin covering the area of
extravasation will be performed to assure prompt treatment should any deterioration
occur.
- Sequential colour photographs of the involved skin area will be taken.
Inclusion Criteria:
1. Cancer patients treated with anthracycline
2. Informed consent obtained from the patient.
3. Suspicion of anthracycline extravasation is 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:
- pain
- swelling
- redness
4. The Topotect infusion must be started <6 hours after the accident.
5. The patient must be at least 18 years of age.
6. Performance status (PS) ≤2.
7. Suspicion of anthracycline extravasation from a central venous access device. -
Exclusion Criteria:
1. Known allergy towards dexrazoxane.
2. 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.
3. AST, ALT, bilirubin, LDH, serum alkaline phosphatase >3 x upper normal value
4. Neutropenia and thrombocytopenia ≥ CTC grade 2
5. Pregnant or nursing women
6. Women of childbearing age and potential, where the patient does not agree to use an
efficient contraceptive (e.g. birth control pill or an intra-uterine device for 3
months previous to start of the trial medication or diaphragm plus a spermicide).
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The rate of surgical resection necessity by progressing necrosis
Principal Investigator
Henning T Mouridsen, MD, Dr. med.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Rigshospitalet, The Finsen Centre 5074, Blegdamsvej 9, DK-2100 Copenhagen
Authority:
Denmark: Ethics Committee
Study ID:
TT01
NCT ID:
NCT00548561
Start Date:
June 2001
Completion Date:
July 2003
Related Keywords:
- Anthracycline Extravasation
- extravasation
- anthracyclines
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