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

PHASE4TerminatedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Solid Cancer Metastatic DiseaseLymphoid 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

Trial Locations (2)

14000

CHU, Caen

14076

Centre François Baclesse, Caen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

collaborator

Roche Pharma AG

INDUSTRY

collaborator

Vifor Pharma

INDUSTRY

lead

Centre Francois Baclesse

OTHER