A therapeutic and pharmacokinetic study of Savene (dexrazoxane) in the treatment of accidental anthracycline extravasation

TopoTarget A/S0 个研究点目标入组 15 人开始时间: 2006年2月21日最近更新: 2013年4月22日

适应症

试验速览

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•1. Cancer patients in chemotherapy with anthracyclines
•2. Extravasation (leakage) of anthracycline suspected according to:
•a) a primary assessment by the physician
•b) presence of at least one of the following symptoms - pain, swelling, or redness
•at the site where the anthracycline leakage is suspected to have occured
•suspicion of anthracycline extravasation from a central venous access device
•3. The Savene treatment must be started within 6 hours after the accident
•4. Age more or equal to 18 years
•5. Performance status 2 or less
•6. Informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Known allergy towards dexrazoxane
•2. reasonable suspision of extravasation of other vesicant compounds than
•anthracyclines through the same intravenous access
•3. AST or ALT, bilirubin, alkaline phosphatase > 3 x upper normal value
•4. WBC < or equal to 1.5 x 1o 9/L and platelets < or equal to 75 x 10 9/L
•5. Administration of dexrazoxane within the last 3 weeks or administration of other
•extravasation treatments than those described in the protocol
•6. Pregnant or breast feeding women
•7. Women of childbearing age and potential, who do not use an efficient contraceptive (such as oral contraception, IUD intrauterine device, depot of gestagen, vaginal hormone ring or transdermal depot patch) for at least 7 days after the dexrazoxane treatment.
•A pregnancy test should be performed on day 1, if possible by a dipstick method to be read immediately. However, treatment should not be delayed.

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