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Sponsored by: |
TopoTarget A/S |
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Information provided by: | TopoTarget A/S |
ClinicalTrials.gov Identifier: | NCT00548561 |
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 II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-Cancer Agents |
Estimated Enrollment: | 25 |
Study Start Date: | July 2001 |
Estimated Study Completion Date: | July 2003 |
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:
Secondary:
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
Denmark | |
Rigshospitalet | |
Copenhagen, Denmark, 2100 | |
Herlev County Hospital | |
Herlev, Denmark, 2730 | |
Naestved District Hospital | |
Naestved, Denmark, 4700 | |
Hilleroed Hospital | |
Hilleroed, Denmark, 3400 | |
Roskilde County Hospital | |
Roskilde, Denmark, 4000 | |
Odense University Hospital | |
Odense, Denmark, 5000 C | |
Vejle Hospital | |
Vejle, Denmark, 7100 | |
Herning District Hospital | |
Herning, Denmark, 7400 | |
Aarhus County hospital | |
Aarhus, Denmark, 8000 C | |
Aalborg Hospital South | |
Aalborg, Denmark, 9100 | |
Viborg Hospital | |
Viborg, Denmark, 8800 | |
Soenderborg Hospital | |
Soenderborg, Denmark, 6400 | |
Esbjerg District Hospital | |
Esbjerg, Denmark, 6700 | |
Aarhus Municipality Hospital | |
Aarhus, Denmark, 8000 C |
Principal Investigator: | Henning T Mouridsen, MD, Dr. med. | Rigshospitalet, The Finsen Centre 5074, Blegdamsvej 9, DK-2100 Copenhagen |
Study ID Numbers: | TT01 |
Study First Received: | October 23, 2007 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00548561 History of Changes |
Health Authority: | Denmark: Ethics Committee; Denmark: Danish Medicines Agency |
extravasation anthracyclines |
Chelating Agents Cardiovascular Agents Razoxane |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Chelating Agents |
Cardiovascular Agents Pharmacologic Actions Razoxane |