Clinical trial · Interventional
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
NCT00548561CI-TRIAL-00019548completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to avoid surgical intervention following extravasation of anthracycline chemotherapy out of a vessel into the surrounding tissues.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anthracycline Extravasation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexrazoxane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The rate of surgical resection necessity by progressing necrosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- RESULTMouridsen 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. PMID 17185744