Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines

• Status: Completed
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Onxeo
• Treatments: Dexrazoxane; Razoxane

Criteria

Inclusion Criteria:

1. Cancer patients treated with anthracycline

2. Informed consent obtained from the patient.

3. 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:

• pain

• swelling

• redness

4. The Topotect infusion must be started <6 hours after the accident.

5. The patient must be at least 18 years of age.

6. Performance status (PS) ≤2.

7. Suspicion of anthracycline extravasation from a central venous access device. -

Exclusion Criteria:

1. Known allergy towards dexrazoxane.

2. Reasonable suspicion of extravasation by other compounds than anthracyclines through the same intravenous access, e.g. vincristine, mitomycin, and vinorelbine, all of which may cause ulceration.

3. AST, ALT, bilirubin, LDH, serum alkaline phosphatase >3 x upper normal value

4. Neutropenia and thrombocytopenia ≥ CTC grade 2

5. Pregnant or nursing women

6. Women of childbearing age and potential, where the patient does not agree to use an efficient contraceptive (e.g. birth control pill or an intra-uterine device for 3 months previous to start of the trial medication or diaphragm plus a spermicide).