A phase II study of up-front red blood cell transfusion before chemotherapy followed by maintenance Erythropoetin-alpha subcutaneous support during chemotherapy of anaemic breast-, colorectal- and ovarian cancer patients
| ISRCTN | ISRCTN81146641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81146641 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | N/A |
| Sponsor | Leiden University Medical Centre (LUMC) (The Netherlands) |
| Funders | Comprehensive Cancer Centre (Integraal Kankercentrum) (The Netherlands), Janssen Cilag B.V. (The Netherlands), Ortho Biotech (USA) |
- Submission date
- 27/02/2007
- Registration date
- 27/02/2007
- Last edited
- 20/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A C Ogilvie
Scientific
Scientific
t Lange Land Ziekenhuis
Department of Internal Medicine
P.O. Box 3015
Zoetermeer
2700 KJ
Netherlands
| Phone | +31 (0)79 346 2881 |
|---|---|
| ogilvia1@llz.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase II, non-randomised, non-controlled, multicentre clinical trial |
| Secondary study design | Multi-centre |
| Scientific title | A phase II study of up-front red blood cell transfusion before chemotherapy followed by maintenance Erythropoetin-alpha subcutaneous support during chemotherapy of anaemic breast-, colorectal- and ovarian cancer patients |
| Study acronym | pCATS |
| Study objectives | An upfront Red Blood Cell Transfusion (RBCT) aiming at low-normal Haemoglobin (Hb) levels will ameliorate anemia-caused tumour hypoxia-related resistance to chemotherapy before the start of chemotherapy and may decrease secondary anemia-induced endogenous release of cytokines like Vascular Endothelial Growth Factor (VEGF), osteopontin. The maintenance of optimal Hb levels at this lower-normal range during chemotherapy by weekly maintenance administration of Erythropoetin-alpha (Epo-alpha) subcutaneous (s.c.) at doses with proven safety and efficacy creates optimal conditions for tumour oxygenation, without the presumably high-Hb level associated adverse effects. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Breast cancer, colorectal cancer, ovarian cancer |
| Intervention | Anemia-treatment consisting of preventive RBCT before the start of chemotherapy followed by the maintenance administration of Epo-alpha s.c. during chemotherapy. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Erythropoetin-alpha |
| Primary outcome measure(s) |
1. Hb levels before the start of and during chemotherapy |
| Key secondary outcome measure(s) |
1. Global Quality of Life (QoL) determined by a measurement on a Linear visual Analog Scale Assessment (LASA) |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 23 |
| Key inclusion criteria | 1. Histological or cytological documentation of breast- or colorectal- or ovarian cancer 2. Age greater than or equal to 18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of zero, one or two 4. Being scheduled to receive chemotherapy or having received already one cycle of chemotherapy and being scheduled to receive at least three cycles of chemotherapy prior to study entry 5. Life expectancy of at least six months 6. Signed written informed consent obtained prior to study entry 7. Anaemia: Hb less than 7.0 mmol/L tested within seven days before enrolment 8. Adequate bone marrow function as assessed within seven days before enrolment by: a. absolute neutrophil count greater than or equal to 1.5 x 10^9/L b. platelets greater than or equal to 100 x 10^9/L 9. Iron status measurements including levels of ferritin, transferrin, iron and iron saturation within seven days after enrolment 10. Patient is able to comply with scheduled follow up |
| Key exclusion criteria | Excluded medical conditions: 1. Having more than one cycle of the current chemotherapy administered prior to inclusion 2. Having one cycle of chemotherapy administered before inclusion and scheduled to receive less than three additional cycles 3. Untreated folate or cobalamin deficiency 4. Untreated haemolytic anaemia defined by decreased serum haptoglobulin levels 5. Anaemia due to hypoproliferative or maturation bone marrow disorders 6. Clinically evident untreated congestive heart failure 7. Serious, untreated cardiac arrhythmias 8. Symptoms of untreated coronary heart disease or ischaemia 9. Untreated hypertension 10. History of HIV infection Excluded therapies, medications and conditions, previous and concomitant: 11. Androgen treatment within two months before enrolment 12. Anti-cancer chemotherapy or immunotherapy within four weeks of study entry 13. Darbepoetin or erythropoetin treatment within four weeks before enrolment 14. Bone marrow transplantation or stem cell transplantation within four months of study entry 15. Investigational drug therapy within four weeks of study entry or during this study 16. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of treatment. Adequate birth control measures will be required during the course of the trial 17. Known or suspected allergy to Epo-alpha |
| Date of first enrolment | 15/09/2005 |
| Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
t Lange Land Ziekenhuis
Zoetermeer
2700 KJ
Netherlands
2700 KJ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 20/05/2011 | 20/08/2021 | No | No |
Editorial Notes
20/08/2021: Publication reference added.
