Solid tumours
Conditions
Interventions
Participants will be randomly allocated to the following two arms:
1. Epoetin beta (NeoRecormon®):
Starting dose subcutanously 150 IU/kgBW thrice weekly, adjustment up to 300 IU/ kgBW thrice weekly
2
the follow up is still ongoing
Sponsors
BioGeneriX AG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent 2. Adult (age=18 years) patients of any ethnic origin 3. Male or female; if female, the patient must meet one of the following criteria: 3.1. postmenopausal for at least one year 3.2. surgical sterilisation or hysterectomy at least 3 months before the start of the study 3.3. absolute sexual abstinence throughout the participation in the study 3.4. women with childbearing potential must use double contraception consisting of hormonal treatment (birth control pill, injection or implant, IUD) plus condom or diaphragm. In women with childbearing potential a pregnancy test (HCG in urine) should be performed in the trial centre at inclusion and every 4 weeks during the treatment period and 4 weeks after the last administration of study medication. 4. Anaemia caused by platinum-based chemotherapeutic treatment defined by a documented haemoglobin concentration of =11g/dL after the last chemotherapy prior to inclusion 5. Histologically or cytologically proven diagnosis of a solid tumour 6. At least one previous platinum-based chemotherapy cycle as treatment of the current malignancy during the last 4 weeks 7. At least two additional platinum-based chemotherapy cycles or two months of platinum-based chemotherapy planned 8. Eastern Co-operative Oncology Group (ECOG) performance status 0, 1, 2 or 3 9. The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breast feeding 2. Any other primary haematologic disorder that would cause anaemia (e.g. sickle cell anaemia) 3. Anaemia of unknown origin 4. Acute or chronic bleeding 5. Any erythropoietin given during the last 4 weeks or ongoing treatment with other erythropoietins 6. Patients who have been treated with Epoetins with a longer half life time (e.g. novel erythropoiesis stimulating protein [NESP], continuous erythropoietin receptor activator [CERA]) within the last 6 months 7. Known presence of antibodies to Epoetin 8. More than two red blood cell transfusions within 4 weeks before inclusion or any red blood cell transfusions within the last 2 weeks 9. Malignancy of the head or neck 10. Life expectancy less than 3 months 11. Candidate for bone marrow or stem cell transplantation 12. Chemotherapy during the last 7 days before study start 13. Radiotherapy or surgery during the last 14 days before inclusion or planned during the conduct of the study 14. Clinically significant concomitant diseases or condition unrelated to the underlying malignancy or chemotherapy 15. Systemic infection or inflammatory disease 16. Known hypersensitivity (drug intolerance or allergy) to erythropoietin, mammalian cell products or excipients of the formulation 17. History of myocardial infarction, cerebrovascular incident, percutaneous transluminal coronary angioplasty or coronary artery bypass graft within the six months prior to enrolment 18. Uncontrolled severe hypertension or hypertension defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg 19. Congestive heart failure according to New York Heart Association (NYHA) class III or IV 20. Thrombocytosis or thrombocytopenia (platelet count 550 x 109/L) 21. Iron deficiency (Serum ferritin =100 µg/L or TSAT = 20%), defined as follows: No serum ferritin > 100µg/L and TSAT > 20% within the last five weeks before randomisation (For clarification: A patient showing for serum ferritin and for Transferrin Saturation [TSAT] at least one value above these limits during the last five weeks before randomisation can be randomised) 22. Known untreated vitamin B12 or folic acid deficiency, defined by the respective laboratory value at baseline plus clinical symptoms of the deficiency 23. Known positive test for human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C 24. Epilepsia, severe endogenous depression or schizophrenia 25. Known impairment of hepatic function 26. Known impairment of renal function 27. History or suspicion of unreliability, poor co-operation or non-compliance with medical treatment 28. History of, or known current problems with drug or alcohol abuse 29. Any other condition that, in the investigator?s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study 30. Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints 31. Participation in a study with investigational drugs within 30 days prior to enrolment or during this study 32. Prior inclusion in the same study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with a complete haemoglobin response defined as the increase in haemoglobin of = 2 g/dL from baseline without the benefit of a transfusion within the previous four weeks. Haemaematology parameters were measured weekly throughout the 12 week treatment phase; transfusions were documented weekly | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of patients having a partial haemoglobin response (defined as increase of = 1g/dL from baseline and no need for transfusion within the last four weeks) 2. Number of patients having a complete haemoglobin response with the initial dose (weekly starting dose for XM01: 20000 IU; for Epoetin beta: 450 IU/kgBW) and no need for transfusion within the last four weeks 3. Number of patients having partial haemoglobin response with the initial dose and no need for transfusion within the last four weeks 4. Number of patients receiving transfusions 5. Number of blood units transfused 6. Time course of haemoglobin, haematocrit and reticulocytes Haemaematology parameters were measured weekly throughout the 12 week treatment phase; transfusions were documented weekly 7. Quality of Life assessed by Functional Assessment of Cancer Therapy - Anaemia (FACT-An) (includes FACT-G [General] and FACT-F [Fatigue]). Measurement at baseline, after 6 weeks and at the end of study (12 weeks) 8. Dose of XM01 or Epoetin beta at the time of complete/ partial haemoglobin response. The weekly dose was documented at the time when the patient achieved a partial or complete response | — |
Countries
Argentina, Belarus, Brazil, Bulgaria, Croatia, India, Moldova, Romania, Russian Federation, Ukraine
Outcome results
None listed