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

Phase 2/3 Completed 57 enrolled Valerio Therapeutics

Non-randomizedSingle-groupOpen-labelTreatment

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

Timeline

Start: 2002-04
Primary completion: 2005-08
Completion: 2005-08

Publications

Results Mouridsen HT, Langer SW, Buter J, Eidtmann H, Rosti G, de Wit M, Knoblauch P, Rasmussen A, Dahlstrom K, Jensen PB, Giaccone G. Treatment of anthracycline extravasation with Savene (dexrazoxane): results from two prospective clinical multicentre studies. Ann Oncol. 2007 Mar;18(3):546-50. doi: 10.1093/annonc/mdl413. Epub 2006 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexrazoxane	Small molecule	1000 mg/m2	Intravenous

Indications

No indication recorded.