Condition category
Cancer
Date applied
02/09/2011
Date assigned
02/09/2011
Last edited
29/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Alison Steel

ORCID ID

Contact details

Northern Institute of Cancer Research
Paul O'Gorman Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Additional identifiers

EudraCT number

2009-011454-17

ClinicalTrials.gov number

NCT01095926

Protocol/serial number

8609

Study information

Scientific title

Phase II pharmacokinetic study to assess the age-dependency in the clearance of doxorubicin in paediatric patients with solid tumours and leukaemia

Acronym

Study hypothesis

Doxorubicin is widely used in the treatment of children's cancer, but little is known about how rapidly the drug is metabolised and removed from the body, particularly in very young children. The study brings together investigators in the UK, in France, Germany and Italy to investigate whether the rate of metabolism and removal is related to age or to the toxicity caused by treatment with doxorubicin. Because children's cancer is relatively rare, in order to recruit sufficient patients it is necessary to run the study in multiple clinical centres across four different countries. This study is funded by the FP7-programme of the European Union, specifically to obtain information on drugs like doxorubicin, where the drug is widely-used, but there are gaps in our knowledge.

Ethics approval

Sunderland Research Ethics Committee, 26/04/2010, ref: 10/H090/22

Study design

Non-randomised, interventional and observational

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Paediatric Oncology, Leukaemia (acute), Leukaemia (chronic), Multiple Sites, Leukaemia (acute myeloid), Leukaemia (acute lymphoblastic), Leukaemia (acute promyelocytic)

Intervention

1. Collection of blood sample for genetic analysis
2. Collection of blood samples for drug and toxicity marker analysis

Intervention type

Drug

Phase

Phase II

Drug names

Doxorubicin

Primary outcome measures

The primary outcome will be when the data has been collected & analysed from all the 100 patients at the end of the study.

1. Pharmacokinetic data to enable assessment of age-dependency of doxorubicin in paediatric patients
2. Pharmacokinetic data available on 100 paediatric patients including at least 5 patients <1 year old

Secondary outcome measures

The outcome of an interim analysis on the data from the first 30 patients is expected to be reported early 2012

Overall trial start date

16/01/2011

Overall trial end date

28/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients less than or equal to 17 years of age
2. Plan to receive at least 2 cycles of doxorubicin
3. Must be enrolled in a national or European protocol for treatment of Wilms 4.Turmours, Neuroblastoma, Soft tissue sarcome, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol or patients under 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy.
5. Patients, parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations
6. Patients that are able to understand should provide assent to participate in the trial
7. Life expectancy is >3 months
8. Karnofsky performance status of >/=70%
9. Additional blood withdrawal is acceptable to the patient. (the decision is left to the investigator)
10. Either male or female

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 25

Participant exclusion criteria

Prior cardiac problems

Recruitment start date

16/01/2011

Recruitment end date

28/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northern Institute of Cancer Research
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Trust (UK)

Sponsor details

Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Government

Funder name

Commission of the European Communities (Europe)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25925711

Publication citations

Additional files

Editorial Notes

29/03/2016: Publication reference added.