Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.
Drug: iron sucrose injection USP
Drug: stable erythropoietin therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy|
- Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). [ Time Frame: During Stage 2 (week 9 through week 21) ] [ Designated as safety issue: No ]The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||December 2005|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
|Active Comparator: Venofer + erythropoietin (responders)||Drug: iron sucrose injection USP|
|Active Comparator: erythropoietin only (responders)||Drug: stable erythropoietin therapy|
|Active Comparator: Venofer+erythropoietin(non-responders)||Drug: iron sucrose injection USP|
|Active Comparator: erythropoietin only (non-responders)||Drug: stable erythropoietin therapy|
This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.