Status:
TERMINATED
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
Lead Sponsor:
Centre Francois Baclesse
Collaborating Sponsors:
Hospira, now a wholly owned subsidiary of Pfizer
Roche Pharma AG
Conditions:
Solid Cancer Metastatic Disease
Lymphoid Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
\- Iron Deficiency and Cancer The literature review therefore presents uncertainties do not allow the routine application of intravenous iron associated with ESAs. The SOR also conclude that IV iron i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02213653
Start Date
April 1 2013
End Date
November 1 2014
Last Update
April 29 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU
Caen, France, 14000
2
Centre François Baclesse
Caen, France, 14076