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

Conditions: Accidental extravasation of anthracyclines
MedDRA version: 7.1Level: prefClassification code 10022062

Registration Number: EUCTR2006-000220-14-DK

Lead Sponsor: TopoTarget A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

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
OR
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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine pharmakokinetic parameter during the 3-day Savene treatment;Secondary Objective: To observe the efficacy of Savene treatment<br>To evaluate safety issues of the Savene tretment;Primary end point(s): Obtainment of a pharmacokinetic profile for the three-day Savene<br>The prevention of: <br>surgical intervention due to the extravasation incident <br>and/or <br>necrosis due to the event<br>late sequelae<br>postponement of planned cytostatic treatment

Secondary Outcome Measures