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

eiden University Medical Centre (LUMC) (The Netherlands)0 个研究点目标入组 23 人开始时间: 2007年2月27日最近更新: 2021年8月30日

适应症

试验速览

•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

•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

发起方

eiden University Medical Centre (LUMC) (The Netherlands)