Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00548561
Recruitment Status : Completed
First Posted : October 24, 2007
Last Update Posted : October 21, 2015
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to avoid surgical intervention following extravasation of anthracycline chemotherapy out of a vessel into the surrounding tissues.

Condition or disease Intervention/treatment Phase
Anthracycline Extravasation Drug: Dexrazoxane Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Study Start Date : June 2001
Actual Primary Completion Date : July 2003
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: Onxeo Identifier: NCT00548561     History of Changes
Other Study ID Numbers: TT01
First Posted: October 24, 2007    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: November 2013

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