A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracyclines

This study has been completed.
Sponsor:
Information provided by:
TopoTarget A/S
ClinicalTrials.gov Identifier:
NCT00548704
First received: October 23, 2007
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
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 Topotect® (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:

Enrollment: 57
Study Start Date: April 2002
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00548704

Locations
Denmark
Aalborg Hospital South
Aalborg, Denmark, 9100
Aarhus County Hospital
Aarhus, Denmark, 8000 C
Aarhus Municipality Hospital
Aarhus, Denmark, 8000 C
Rigshospitalet, Oncology Department
Copenhagen, Denmark, 2100
Rigshospitalet, Haematology Department
Copenhagen, Denmark, 2100
Esbjerg District Hospital
Esbjerg, Denmark, 6700
Herlev County Hospital, Oncology Department
Herlev, Denmark, 2730
Herlev County Hospital, Haematology Department
Herlev, Denmark, 2730
Hilleroed Hospital
Hilleroed, Denmark, 3400
Naestved District Hospital
Naestved, Denmark, 4700
Odense University Hospital
Odense, Denmark, 5000 C
Roskilde County Hospital
Roskilde, Denmark, 4000
Soenderborg Hospital
Soenderborg, Denmark, 6400
Vejle Hospital
Vejle, Denmark, 7100
Viborg Hospital
Viborg, Denmark, 8800
Germany
Evangelisches Bethesda Krankenhaus
Essen Borbak Statt, Germany, 45355
Klinik für Gynäkologie und Geburtshilfe
Frankfurt am Main, Germany, 60590
Klinik und Poliklinik für Innere Medizin
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30659
Universitäts Frauenklinik
Kiel, Germany, 24105
Universitäts Medizinische Klinik
Kiel, Germany, 24105
Frauenklinik com Roten Kreuz
Munich, Germany, 80637
Universitäts Frauenklinik
Rostock, Germany, 18057
Klinik für Gynäkologie und Gynäkologische Onkologie
Wiesbaden, Germany, 65199
Italy
Ospedale G.B. Morgagni L. Pierantoni
Forli, Italy, 47100
Presidio Ospedaliero di Ravenna
Ravenna, Italy, 48100
Ospedale degli Infermi
Rimini, Italy, 47037
Ospedali Riuniti
Trieste, Italy, 34100
Netherlands
Netherland Cancer Instituet
Amsterdam, Netherlands, 1066 CX
University Hospital
Groningen, Netherlands, 9700 RB
Willem Alexander Hospital
Hertogenbosch, Netherlands, 5223 GV
Poland
Centre of Oncology - Krakow Division
Krakow, Poland, 31-115
Maria Sklodowska-Curie Memorial Cancer Center
Warsaw, Poland, 02-781
Dolnoslaski Centrum Onkologii oddzial Chemoterapii
Wroclaw, Poland, 53-413
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: NCT00548704     History of Changes
Other Study ID Numbers: TT02
Study First Received: October 23, 2007
Last Updated: November 28, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency
Netherlands: Medical Ethics Review Committee (METC)
Germany: Ethics Commission
Italy: Ethics Committee
Poland: Ministry of Health

Keywords provided by TopoTarget A/S:
Extravasation
Anthracyclines

Additional relevant MeSH terms:
Antineoplastic Agents
Razoxane
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014