NCT00548561

Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines

A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Valerio Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Anthracycline Extravasation

Interventions

Type	Name	Description
DRUG	Dexrazoxane

Timeline

• Start date: 2001-06-01
• Primary completion: 2003-07-01
• Completion: 2003-07-01
• First posted: 2007-10-24
• Last updated: 2015-10-21

Locations

9 sites across 1 country: Denmark