NCT00548704

Brief 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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2002

Typical duration for phase_2

Geographic Reach
5 countries

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
Last Updated

October 21, 2015

Status Verified

November 1, 2013

Enrollment Period

3.3 years

First QC Date

October 23, 2007

Last Update Submit

October 20, 2015

Conditions

Extravasation

Keywords

ExtravasationAnthracyclines

Interventions

DexrazoxaneDRUG
Also known as: Totect

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All cancer patients treated with anthracyclines
  • Informed consent must be obtained from the patient
  • Patients suspected to have been exposed to extravasation (leakage) of anthracycline, 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 symptoms: pain, swelling or redness at the site where the anthracycline leakage is suspected to have occurred.
  • Suspicion of anthracycline extravasation from a central venous access device
  • The Topotect® infusion must be started \< 6 hours after the accident
  • years of age or older
  • Performance status (PS) \< 2

You may not qualify if:

  • Known allergy towards dexrazoxane
  • 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
  • AST (aspartate aminotransferase) or ALT (alanine aminotransferase), bilirubin, LDH (lactate dehydrogenase), alkaline phosphatase \>3 x upper normal value
  • Neutrophils CTC (common toxicity criteria) ≥ grade 2. (neutrophils 1.5 x 109/L, ≥1,500/mm3)
  • Platelets CTC ≥ grade 2. (platelets ≥75.0 x 109/L, \<75,000/mm3).
  • Topical use of DMSO (dimethylsulfoxide) at the area of the accident
  • Administration of dexrazoxane within the last 3 weeks
  • Pregnant or nursing women
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Aalborg Hospital South

Aalborg, 9100, Denmark

Location

Aarhus County Hospital

Aarhus, 8000 C, Denmark

Location

Aarhus Municipality Hospital

Aarhus, 8000 C, Denmark

Location

Rigshospitalet, Haematology Department

Copenhagen, 2100, Denmark

Location

Rigshospitalet, Oncology Department

Copenhagen, 2100, Denmark

Location

Esbjerg District Hospital

Esbjerg, 6700, Denmark

Location

Herlev County Hospital, Haematology Department

Herlev, 2730, Denmark

Location

Herlev County Hospital, Oncology Department

Herlev, 2730, Denmark

Location

Hilleroed Hospital

Hilleroed, 3400, Denmark

Location

Naestved District Hospital

Næstved, 4700, Denmark

Location

Odense University Hospital

Odense, 5000 C, Denmark

Location

Roskilde County Hospital

Roskilde, 4000, Denmark

Location

Soenderborg Hospital

Sønderborg, 6400, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

Viborg Hospital

Viborg, 8800, Denmark

Location

Evangelisches Bethesda Krankenhaus

Essen Borbak Statt, 45355, Germany

Location

Klinik für Gynäkologie und Geburtshilfe

Frankfurt am Main, 60590, Germany

Location

Klinik und Poliklinik für Innere Medizin

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30659, Germany

Location

Universitäts Frauenklinik

Kiel, 24105, Germany

Location

Universitäts Medizinische Klinik

Kiel, 24105, Germany

Location

Frauenklinik com Roten Kreuz

Munich, 80637, Germany

Location

Universitäts Frauenklinik

Rostock, 18057, Germany

Location

Klinik für Gynäkologie und Gynäkologische Onkologie

Wiesbaden, 65199, Germany

Location

Ospedale G.B. Morgagni L. Pierantoni

Forlì, 47100, Italy

Location

Presidio Ospedaliero di Ravenna

Ravenna, 48100, Italy

Location

Ospedale degli Infermi

Rimini, 47037, Italy

Location

Ospedali Riuniti

Trieste, 34100, Italy

Location

Willem Alexander Hospital

's-Hertogenbosch, 5223 GV, Netherlands

Location

Netherland Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

University Hospital

Groningen, 9700 RB, Netherlands

Location

Centre of Oncology - Krakow Division

Krakow, 31-115, Poland

Location

Maria Sklodowska-Curie Memorial Cancer Center

Warsaw, 02-781, Poland

Location

Dolnoslaski Centrum Onkologii oddzial Chemoterapii

Wroclaw, 53-413, Poland

Location

Related Publications (1)

  • Mouridsen 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: 17185744RESULT

MeSH Terms

Interventions

DexrazoxaneRazoxane

Intervention Hierarchy (Ancestors)

DiketopiperazinesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Henning T Mouridsen, MD, Dr. med.

    Rigshospitalet, The Finsen Centre 5074, Blegdamsvej 9, DK-2100 Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 24, 2007

Study Start

April 1, 2002

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

October 21, 2015

Record last verified: 2013-11

Locations

DK(15)PL(3)DE(9)NL(3)IT(4)