Condition category
Cancer
Date applied
27/02/2007
Date assigned
27/02/2007
Last edited
27/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A C Ogilvie

ORCID ID

Contact details

’t Lange Land Ziekenhuis
Department of Internal Medicine
P.O. Box 3015
Zoetermeer
2700 KJ
Netherlands
+31 (0)79 346 2881
ogilvia1@llz.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

pCATS

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Phase II, non-randomised, non-controlled, multicentre clinical trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Erythropoetin-alpha

Primary outcome measures

1. Hb levels before the start of and during chemotherapy
2. Safety of the pCATS anaemia treatment regimen

Secondary outcome measures

1. Global Quality of Life (QoL) determined by a measurement on a Linear visual Analog Scale Assessment (LASA)
2. Length of treatment duration and time to treatment failure

Overall trial start date

15/09/2005

Overall trial end date

01/09/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

23

Participant 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

Recruitment start date

15/09/2005

Recruitment end date

01/09/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

’t Lange Land Ziekenhuis
Zoetermeer
2700 KJ
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

Department of Clinical Oncology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html

Funders

Funder type

Industry

Funder name

Comprehensive Cancer Centre (Integraal Kankercentrum) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Janssen Cilag B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ortho Biotech (USA)

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

Publication citations

Additional files

Editorial Notes