Randomised study on haemoglobin response in iron-deficient anaemic patients with solid malignancies receiving epoetin alfa (rHuEPO) in combination with either oral or parental iron supplementation during treatment with non-platinum containing chemotherapy

Completed

Conditions: Anaemia
Haematological Disorders
Anaemia in chronic diseases classified elsewhere

Registration Number: ISRCTN61345286

Lead Sponsor: Vrije University Medical Centre (VUMC) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 34

Inclusion Criteria

1. Confirmed diagnosis of a solid malignancy and planned to receive further non-platinum containing chemotherapy for at least 12 weeks
2. Haemoglobin (Hb) less than or equal to 7.5 mmol/L at any time during chemotherapy
3. Transferrin saturation (TSAT) less than 20% and/or serum ferritin less than 100 ng/ml
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
5. Life expectancy at least 3 months
6. Aged 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. Mean corpuscular volume (MCV) less than 80 fL and mean corpuscular haemoglobin count (MCHC) less than 195 mmol/L
2. MCV greater than 100 fL
3. Clinically significant chronic blood loss
4. Clinically significant disease/dysfunction of the pulmonary, cardiovascular, 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