A double-blind, placebo controlled study to assess the effects of early intervention and/or treatment with epoetin alfa on anaemia in cancer patients receiving non-platinum containing chemotherapy

ISRCTN ISRCTN98318971
DOI https://doi.org/10.1186/ISRCTN98318971
Secondary identifying numbers GN308
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
19/02/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAnaemia
InterventionPatients are randomised to one of two treatment arms:
1. Arm A: Patients receive 150 IU/Kg of Epoetin alpha
2. Arm B: Patients receive matching placebo

Epoetin alpha or placebo is given subcutaneously three times per week for the first four weeks (or the first on-study chemotherapy cycle, respectively). Haemaglobin level and/or reticulocyte count will then be used to determine whether the same dose (volume) or a doubled dose (volume) will be used for the remainder of the treatment.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2003
Completion date01/01/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Diagnosis of non-myeloid malignancy, which requires non-platinum containing chemotherapy
2. Predicted chemotherapy of 12 to 24 weeks (three to six cycles) duration
3. Performance score zero to three
4. Life expectancy of more than six months
5. Aged over 18 years
6. Patients with acute leukaemia are excluded
7. No myeloablative chemotherapy
8. No uncontrolled hypertension
9. No evidence of untreated iron, folate or vitamin B12 deficiency
Key exclusion criteriaDoes not comply with the above inclusion criteria
Date of first enrolment01/01/2003
Date of final enrolment01/01/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Janssen-Cilag Ltd (UK)
Industry

Saunderton
High Wycombe
HP14 4HJ
United Kingdom

Phone +44 (0)1494 567567
Website http://www.janssen-cilag.co.uk
ROR logo "ROR" https://ror.org/03qwpn290

Funders

Funder type

Industry

Janssen-Cilag Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan