Anthracycline ExtravasationPhase 2/3NCT00548561
Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines
A Phase 2/3 study testing Dexrazoxane in people with Anthracycline Extravasation, run by Valerio Therapeutics at 9 sites in Denmark.
Trial summary
The purpose of this study is to avoid surgical intervention following extravasation of anthracycline chemotherapy out of a vessel into the surrounding tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anthracycline Extravasation
- What is being tested?
- Dexrazoxane
- How many people
- 23 participants
- Where
- 9 sitesDenmark
- Study dates
- Jun 2001to Jul 2003
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients treated with anthracycline
- Informed consent obtained from the patient.
- 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
Show all 12Show fewer
- swelling
- redness
- The Topotect infusion must be started <6 hours after the accident.
- The patient must be at least 18 years of age.
- Performance status (PS) ≤2.
- Suspicion of anthracycline extravasation from a central venous access device. -
Who cannot join
- 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, ALT, bilirubin, LDH, serum alkaline phosphatase >3 x upper normal value
- Neutropenia and thrombocytopenia ≥ CTC grade 2
- Pregnant or nursing women
- 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).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites
Aalborg Hospital South
Aalborg, 9100
Rigshospitalet
Copenhagen, 2100
Herlev County Hospital
Herlev, 2730
Herlev Hospital Hematological Department
Herlev, 2730
Herning District Hospital
Herning, 7400
Hilleroed Hospital
Hilleroed, 3400
Odense University Hospital
Odense, 5000 C
Roskilde County Hospital
Roskilde, 4000
Viborg Hospital
Viborg, 8800
About this study
Official title: A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
The purpose of this study is to avoid surgical intervention following extravasation of anthracycline chemotherapy out of a vessel into the surrounding tissues.
Read the detailed description
Accidental extravasation of anthracyclines including doxorubicin and its derivative epirubicin, may cause severe, progressive tissue necrosis requiring the surgical removal of any damaged tissue. Thus, the patient is subjected to major surgery causing substantial delay of the treatment of the primary cancer disease.
Tissue infiltration by anthracyclines may be detected by fluorescence microscopy. This test is performed at most hospitals in Denmark.
In a large preclinical trial, as well as 4 clinical cases, dexrazoxane has proven to prevent these severe tissue necroses. This trial will determine the effect of dexrazoxane as an acute treatment (acute antidote) in patients with anthracycline extravasation verified by fluorescence biopsy.
Purpose
Primary:
- To avoid surgical intervention following the accidental extravasation of anthracycline drug, and thus preventing the patient from sequelae.
Secondary:
- To avoid deleterious postponement of the cancer treatment itself.
- To evaluate and describe subjective and objective symptoms in the damaged area following treatment with TopotectTM.
- To evaluate tolerability/toxicity of TopotectTM used for this indication, according to the indicated schedule.
Trial Population 25 patients with accidental anthracycline extravasation confirmed by fluorescence microscopy
Trial Design Open-label clinical trial. Twenty-five consecutive patients with an acute (<6 hours) history of anthracycline extravasation confirmed by fluorescence microscopy (who in general practice are candidates for acute plastic surgical intervention) will be included.
Effect Variables Response rates, presence of late sequelae, time to progression, and clinical consequence of progression.
Safety Features
- Any toxicity caused by TopotectTM will be studied by blood tests, systematic questioning regarding subjective discomfort, as well as by objective clinical examination.
- A systematic clinical evaluation of the marked area of skin covering the area of extravasation will be performed to assure prompt treatment should any deterioration occur.
- Sequential colour photographs of the involved skin area will be taken.
- Conditions
- Anthracycline Extravasation
- Being tested
- Dexrazoxane
- Keywords
- extravasation, anthracyclines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexrazoxaneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of surgical resection necessity by progressing necrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study startJun 2001
- Primary completionJul 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anthracycline ExtravasationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valerio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henning T Mouridsen, MD, Dr. med., Principal investigator, Rigshospitalet, The Finsen Centre 5074, Blegdamsvej 9, DK-2100 Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548561
- Sponsor's protocol ID
- TT01
- Status last verified
- Nov 2013
- First submitted
- 23 Oct 2007
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17185744
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
- ClinicalTrials.gov ID
- NCT00548561
- Acronym / sponsor ID
- TT01
- Conditions
- Anthracycline Extravasation
- Keywords
- extravasation, anthracyclines
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Valerio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 24 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to avoid surgical intervention following extravasation of anthracycline chemotherapy out of a vessel into the surrounding tissues.
Detailed description
Accidental extravasation of anthracyclines including doxorubicin and its derivative epirubicin, may cause severe, progressive tissue necrosis requiring the surgical removal of any damaged tissue. Thus, the patient is subjected to major surgery causing substantial delay of the treatment of the primary cancer disease.
Tissue infiltration by anthracyclines may be detected by fluorescence microscopy. This test is performed at most hospitals in Denmark.
In a large preclinical trial, as well as 4 clinical cases, dexrazoxane has proven to prevent these severe tissue necroses. This trial will determine the effect of dexrazoxane as an acute treatment (acute antidote) in patients with anthracycline extravasation verified by fluorescence biopsy.
Purpose
Primary:
- To avoid surgical intervention following the accidental extravasation of anthracycline drug, and thus preventing the patient from sequelae.
Secondary:
- To avoid deleterious postponement of the cancer treatment itself.
- To evaluate and describe subjective and objective symptoms in the damaged area following treatment with TopotectTM.
- To evaluate tolerability/toxicity of TopotectTM used for this indication, according to the indicated schedule.
Trial Population 25 patients with accidental anthracycline extravasation confirmed by fluorescence microscopy
Trial Design Open-label clinical trial. Twenty-five consecutive patients with an acute (<6 hours) history of anthracycline extravasation confirmed by fluorescence microscopy (who in general practice are candidates for acute plastic surgical intervention) will be included.
Effect Variables Response rates, presence of late sequelae, time to progression, and clinical consequence of progression.
Safety Features
- Any toxicity caused by TopotectTM will be studied by blood tests, systematic questioning regarding subjective discomfort, as well as by objective clinical examination.
- A systematic clinical evaluation of the marked area of skin covering the area of extravasation will be performed to assure prompt treatment should any deterioration occur.
- Sequential colour photographs of the involved skin area will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Cancer patients treated with anthracycline
- Informed consent obtained from the patient.
- 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 Topotect infusion must be started <6 hours after the accident.
Key exclusion criteria (6 listed)
- 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, ALT, bilirubin, LDH, serum alkaline phosphatase >3 x upper normal value
- Neutropenia and thrombocytopenia ≥ CTC grade 2
- Pregnant or nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexrazoxane | Drug | – |
Primary outcome
The rate of surgical resection necessity by progressing necrosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Results publication: PubMed 17185744Mouridsen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning T Mouridsen, MD, Dr. med. principal investigator
Rigshospitalet, The Finsen Centre 5074, Blegdamsvej 9, DK-2100 Copenhagen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexrazoxane in people with Anthracycline Extravasation, run by Valerio Therapeutics at 9 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of surgical resection necessity by progressing necrosis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00548561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.