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Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines

This study has been completed.
Sponsor:
Information provided by:
TopoTarget A/S
ClinicalTrials.gov Identifier:
NCT00548561
First received: October 23, 2007
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 TopoTarget A/S:

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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548561

Locations
Denmark
Aalborg Hospital South
Aalborg, Denmark, 9100
Rigshospitalet
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
TopoTarget A/S
Investigators
Principal Investigator: Henning T Mouridsen, MD, Dr. med. Rigshospitalet, The Finsen Centre 5074, Blegdamsvej 9, DK-2100 Copenhagen
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00548561     History of Changes
Other Study ID Numbers: TT01
Study First Received: October 23, 2007
Last Updated: November 28, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency

Keywords provided by TopoTarget A/S:
extravasation
anthracyclines

Additional relevant MeSH terms:
Dexrazoxane
Razoxane
Antimitotic Agents
Antineoplastic Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014