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A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of 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.
 
ClinicalTrials.gov Identifier: NCT00548704
Recruitment Status : Completed
First Posted : October 24, 2007
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Onxeo

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Study Start Date : April 2002
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Dexrazoxane
    Other Name: Totect



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. All cancer patients treated with anthracyclines
  2. Informed consent must be obtained from the patient
  3. Patients suspected to have been exposed to extravasation (leakage) of anthracycline, defined as:

    1. A primary assessment by the physician on duty, which would activate the standard departmental procedure for treatment of anthracycline extravasation.
    2. 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.
  4. Suspicion of anthracycline extravasation from a central venous access device
  5. The Topotect® infusion must be started < 6 hours after the accident
  6. 18 years of age or older
  7. Performance status (PS) < 2

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 (aspartate aminotransferase) or ALT (alanine aminotransferase), bilirubin, LDH (lactate dehydrogenase), alkaline phosphatase >3 x upper normal value
  4. Neutrophils CTC (common toxicity criteria) ≥ grade 2. (neutrophils 1.5 x 109/L, ≥1,500/mm3)
  5. Platelets CTC ≥ grade 2. (platelets ≥75.0 x 109/L, <75,000/mm3).
  6. Topical use of DMSO (dimethylsulfoxide) at the area of the accident
  7. Administration of dexrazoxane within the last 3 weeks
  8. Pregnant or nursing women
  9. 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

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 ClinicalTrials.gov identifier (NCT number): NCT00548704


Locations
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Sponsors and Collaborators
Onxeo
Investigators
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Principal Investigator: Henning T Mouridsen, MD, Dr. med. Rigshospitalet, The Finsen Centre 5074, Blegdamsvej 9, DK-2100 Copenhagen
Publications of Results:
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Responsible Party: Onxeo
ClinicalTrials.gov Identifier: NCT00548704    
Other Study ID Numbers: TT02
First Posted: October 24, 2007    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: November 2013
Keywords provided by Onxeo:
Extravasation
Anthracyclines
Additional relevant MeSH terms:
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Dexrazoxane
Razoxane
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