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

• Status: Terminated
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Francois Baclesse
• Collaborators: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer; Roche Pharma AG; Vifor Pharma
• Treatments: Central Nervous System Stimulants; Ferric Compounds; Iron

Criteria

Inclusion Criteria:

• Patient> 18 years;

• Metastatic or locally advanced non-curable undergoing chemotherapy or lymphoid disease for which chemotherapy is indicated solid cancerous disease;

• Patient for which there are at least 3 cycles or 3 months of chemotherapy;

• Haemoglobin between 8.5 and 11 g / dL;

• Functional martial deficiency defined by a coefficient of transferrin saturation and serum ferritin ≤ 20% between 100 and 800 mg / L;

• Life expectancy> 3 months;

• ECOG ≤ 2.

Exclusion Criteria:

• Documented hemochromatosis ;

• AST and / or ALT> 2.5N;

• Renal impairment with Cockcroft clearance <30 mL / min;

• Vitamin B12 deficiency or folate;

• Hemolysis;

• Infectious disease being untreated;

• Haemorrhagic syndrome related or not with the tumor;

• Hypersensitivity to Ferinject ® or any of the excipients;

• Land atopic asthma or eczema known

• Contraindication to EPO;

• Taking a supplement to oral iron;

• Treatment with EPO within 6 months prior to study entry;

• No transfusion of packed red cells within 15 days before enrollment or randomization in the study;

• Participation in another clinical trial;

• Psychiatric pathology can disrupt the course of treatment or prevent the interpretation of results;

• Pregnant or lactating women;

• Persons deprived of liberty;

• Major subject to a measure of legal protection or unable to consent.