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Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines

This study has been completed.
Information provided by (Responsible Party):
Onxeo Identifier:
First received: October 23, 2007
Last updated: October 20, 2015
Last verified: November 2013
The purpose of this study is to avoid surgical intervention following extravasation of anthracycline chemotherapy out of a vessel into the surrounding tissues.

Condition Intervention Phase
Anthracycline Extravasation
Drug: Dexrazoxane
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents

Resource links provided by NLM:

Further study details as provided by Onxeo:

Primary Outcome Measures:
  • The rate of surgical resection necessity by progressing necrosis

Enrollment: 23
Study Start Date: June 2001
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Detailed Description:

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.



• To avoid surgical intervention following the accidental extravasation of anthracycline drug, and thus preventing the patient from sequelae.


  • 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00548561

Aalborg Hospital South
Aalborg, Denmark, 9100
Copenhagen, Denmark, 2100
Herlev County Hospital
Herlev, Denmark, 2730
Herlev Hospital Hematological Department
Herlev, Denmark, 2730
Herning District Hospital
Herning, Denmark, 7400
Hilleroed Hospital
Hilleroed, Denmark, 3400
Odense University Hospital
Odense, Denmark, 5000 C
Roskilde County Hospital
Roskilde, Denmark, 4000
Viborg Hospital
Viborg, Denmark, 8800
Sponsors and Collaborators
Principal Investigator: Henning T Mouridsen, MD, Dr. med. Rigshospitalet, The Finsen Centre 5074, Blegdamsvej 9, DK-2100 Copenhagen
  More Information

Responsible Party: Onxeo Identifier: NCT00548561     History of Changes
Other Study ID Numbers: TT01
Study First Received: October 23, 2007
Last Updated: October 20, 2015

Keywords provided by Onxeo:

Additional relevant MeSH terms:
Antineoplastic Agents
Cardiotonic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimitotic Agents
Mitosis Modulators processed this record on April 28, 2017