Breast cancer, colorectal cancer, ovarian cancer Cancer breast-, colorectal- or ovarian cancer
Conditions
Sponsors
Leiden University Medical Centre (LUMC) (The Netherlands)
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Hb levels before the start of and during chemotherapy 2. Safety of the pCATS anaemia treatment regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed