To determine optimal route of iron supplementation during treatment with non-platinum containing chemotherapy for solid tumors.
ID
Bron
Verkorte titel
Aandoening
IJzerdeficiente anemische patiënten met solide tumoren
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Increase in Hb.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
To determine optimal route of iron supplementation during treatment with non-platinum containing chemotherapy for solid tumors.
Onderzoeksproduct en/of interventie
Epoetine alfa, iron (III)-hydroxyde-sucrose, ferrofumarate.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL214 |
NTR-old | NTR250 |
Ander register | : N/A |
ISRCTN | ISRCTN61345286 |