No registrations found.
ID
Source
Brief title
Health condition
IJzerdeficiente anemische patiënten met solide tumoren
Sponsors and support
Intervention
Outcome measures
Primary outcome
Increase in Hb.
Secondary outcome
Number of required blood transfusions, total dose of administered rHuEPO.
Background summary
N/A
Study objective
To determine optimal route of iron supplementation during treatment with non-platinum containing chemotherapy for solid tumors.
Intervention
Epoetine alfa, iron (III)-hydroxyde-sucrose, ferrofumarate.
Department of Medical Oncology, 6 Z 170,
P.O. Box 7057
Giuseppe Giaccone
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444321
g.giaccone@vumc.nl
Department of Medical Oncology, 6 Z 170,
P.O. Box 7057
Giuseppe Giaccone
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444321
g.giaccone@vumc.nl
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
1. MCV <80fL and MCHC <19.5 mmol/L;
2. 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL214 |
NTR-old | NTR250 |
Other | : N/A |
ISRCTN | ISRCTN61345286 |