Contact information
Type
Scientific
Primary contact
Prof Giuseppe Giaccone
ORCID ID
Contact details
VU Medical Centre
Principal Investigator Medical Oncology
6 Z 170
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 4444321
g.giaccone@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR250
Study information
Scientific title
Acronym
Study hypothesis
To determine optimal route of iron supplementation during treatment with non-platinum containing chemotherapy for solid tumours.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Anaemia
Intervention
Epoetin alfa, iron (III)-hydroxyde-sucrose, ferrofumarate.
Intervention type
Supplement
Phase
Not Specified
Drug names
Iron supplementation, Epoetine alfa, iron (III)-hydroxyde-sucrose, ferrofumarate
Primary outcome measures
Increase in Hb
Secondary outcome measures
1. Number of required blood transfusions
2. Total dose of administered recombinant human erythropoietin alpha (rHuEPO)
Overall trial start date
01/02/2001
Overall trial end date
30/07/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Confirmed diagnosis of a solid malignancy and planned to receive further non-platinum containing chemotherapy for at least 12 weeks
2. Haemoglobin (Hb) less than or equal to 7.5 mmol/L at any time during chemotherapy
3. Transferrin saturation (TSAT) less than 20% and/or serum ferritin less than 100 ng/ml
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
5. Life expectancy at least 3 months
6. Aged between 18 - 75 years
7. Sex: male or female. Female subjects must be either postmenopausal (for at least for 1 year), sterilised or, if of childbearing potential, be practising an acceptable method of birth control.
8. Subjects must have read and signed the informed consent form
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
34
Participant exclusion criteria
1. Mean corpuscular volume (MCV) less than 80 fL and mean corpuscular haemoglobin count (MCHC) less than 195 mmol/L
2. MCV greater than 100 fL
3. Clinically significant chronic blood loss
4. Clinically significant disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurological, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy. This dysfunction is only an exclusion criteria if it causes an expected early withdrawal from the study.
5. Uncontrolled hypertension, defined as a diastolic blood pressure greater than 100 mmHg, despite antihypertensive medication
6. History of seizures
7. Known hypersensitivity to Epoetin alfa or one of its components
8. Administration of intravenous iron preparations within 3 months before study entry
9. Participation in any other clinical trial involving unlicensed medication or procedures
10. Androgen therapy within two months of study entry
Recruitment start date
01/02/2001
Recruitment end date
30/07/2003
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU Medical Centre
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Vrije University Medical Centre (VUMC) (The Netherlands)
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