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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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

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

Details

• Lead Sponsor: Onxeo
• Treatments: Dexrazoxane; Razoxane

Criteria

Inclusion Criteria:

1. All cancer patients treated with anthracyclines

2. Informed consent must be obtained from the patient

3. Patients suspected to have been exposed to extravasation (leakage) of anthracycline, defined as:

1. A primary assessment by the physician on duty, which would activate the standard departmental procedure for treatment of anthracycline extravasation.

2. The presence of at least one of the following symptoms: pain, swelling or redness at the site where the anthracycline leakage is suspected to have occurred.

4. Suspicion of anthracycline extravasation from a central venous access device

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

6. 18 years of age or older

7. Performance status (PS) < 2

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 (aspartate aminotransferase) or ALT (alanine aminotransferase), bilirubin, LDH (lactate dehydrogenase), alkaline phosphatase >3 x upper normal value

4. Neutrophils CTC (common toxicity criteria) ≥ grade 2. (neutrophils 1.5 x 109/L, ≥1,500/mm3)

5. Platelets CTC ≥ grade 2. (platelets ≥75.0 x 109/L, <75,000/mm3).

6. Topical use of DMSO (dimethylsulfoxide) at the area of the accident

7. Administration of dexrazoxane within the last 3 weeks

8. Pregnant or nursing women

9. Women of childbearing age and potential, who do not use an efficient contraceptive (e.g. the Pill or a diaphragm plus a spermicide) for at least 3 months prior to the start of trial medication