IJzerdeficiente anemische patiënten met solide tumoren
Conditions
Interventions
Epoetine alfa, iron (III)-hydroxyde-sucrose, ferrofumarate.
Sponsors
VU medisch centrum
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of a solid malignancy and planned to receive further non-platinum containing chemotherapy for at least 12 weeks; 2. Hb ¡Ü7.5 mmol/L at any time during chemotherapy; 3. TSAT <20% and/or serum ferritin < 100 ng/ml; 4. ECOG Performance Status of 0, 1 or 2; 5. Life expectancy at least 3 months; 6. Age between 18-75 years; 7. Sex: male or female. Female subjects must be either postmenopausal (for at least for 1 year), sterilised or, if of childbearing potential, be practising an acceptable method of birth control; 8. Subjects must have read and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. MCV 100fL; 3. Clinically significant chronic blood loss; 4. Clinically significant disease/dysfunction of the pulmonary, cardio-vascular, endocrine, neurological, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy. This dysfunction is only an exclusion criteria if it causes an expected early withdrawal from the study; 5. Uncontrolled hypertension, defined as a diastolic blood pressure greater than 100 mmHg, despite antihypertensive medication; 6. History of seizures; 7. Known hypersensitivity to Epoetin alfa or one of its components; 8. Administration of intravenous iron preparations within 3 months before study entry; 9. Participation in any other clinical trial involving unlicensed medication or procedures; 10. Androgen therapy within two months of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in Hb. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of required blood transfusions, total dose of administered rHuEPO. | — |
Contacts
Public ContactGiuseppe Giaccone
VU University Medical Center, Department of Medical Oncology, 6 Z 170, P.O. Box 7057
Outcome results
None listed