Phase IV Randomized Study Evaluating Agents Stimulants Erythropoiesis (ASE) Associated With Ferric Carboxymaltose (Ferinject ®) in Concomitant or Sequential Patients Treated for Cancer and With Anemia Associated With Functional Iron Deficiency

NCT02213653 Phase 4 TERMINATED

Anemia in patients with cancer is a common problem associated with an impaired quality of life. Treatment with erythropoiesis stimulating agents (ESA) allows an increase in hemoglobin levels in 40-70% of patients and decreased transfusion requirements. Absolute or functional iron deficiency is also common with about 30% of cancer patients with all histologies combined iron deficiency and anemia. Several studies have shown the benefits of the combination of intravenous iron to erythropoiesis-stimulating agents in improving hemoglobin. However, none of them, to the investigators knowledge, has not been specifically performed on a population of patients with functional iron deficiency. In addition, in clinical practice, this association is not carried out in particular because there is no dosage or consensus sequence for the administration of iron associated with ESAs.

Details

Lead sponsor	Centre Francois Baclesse
Phase	Phase 4
Status	TERMINATED
Enrolment	24
Start date	2013-04
Completion	2014-11

Conditions

• Solid Cancer Metastatic Disease
• Lymphoid Disease

Interventions

• ARM A : IV iron + epoietin zeta
• ARM B: IV iron + epoietin zeta sequence
• ARM C : single epoietin zeta

Primary outcomes

• Number of patients with hematopoietic response at 10 weeks. — The rate of hematopoietic response will be evaluated 10 weeks
  The primary objective is to evaluate the rate of hematopoietic response to 10 weeks in patients with anemia and functional iron deficiency treated epoietin zeta + carboxymaltose concomitant IV iron, by epoietin zeta + carboxymaltose IV ferric sequential or epoietin zeta alone

Countries

France