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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 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-04-29

No results posted yet for this study

Summary

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.

Conditions

  • Solid Cancer Metastatic Disease
  • Lymphoid Disease

Interventions

DRUG

ARM A : IV iron + epoietin zeta

* Epoietin zeta at a dose of 450 IU / kg per week subcutaneously * Carboxymaltose ferric (Ferinject ®) at week 1; Intravenous infusion not exceeding 1000 mg (administered once if weight\> 50 kg, 500 mg twice otherwise, with an interval of one week between each administration). * Renewable with a minimum of 4 weeks depending on the iron status (if CST \<20% and absence of serum ferritin\> 800) in the same manner as week 1.

DRUG

ARM B: IV iron + epoietin zeta sequence

* Epoietin zeta at a dose of 450 IU / kg per week subcutaneously started in week 7 * carboxymaltose ferric (Ferinject ®) at week 1 * Intravenous infusion not exceeding 1000 mg (administered once if weight\> 50 kg, 500 mg twice otherwise, with an interval of one week between each administration). * Renewable with a minimum of 4 weeks depending on the iron status (if CST \<20% and absence of serum ferritin\> 800) in the same manner as week 1.

DRUG

ARM C : single epoietin zeta

Epoietin zeta at a dose of 450 IU / kg per week subcutaneously begun in week 1

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Vifor Pharma

    collaborator INDUSTRY

  • Centre Francois Baclesse

    lead OTHER

Principal Investigators

  • Emmanuel SEVIN, MD · Centre François Baclesse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02213653 on ClinicalTrials.gov