Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Using Intravenous Iron in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia Treated With 120,000 Units Epoetin Alfa Every Three Weeks|
- Achieve hemoglobin responses > 2g/dl in at least 70% of patients [ Time Frame: Nine weeks, after at least two doses of 120,000 units epoetin alfa ] [ Designated as safety issue: No ]
- Descriptive evaluation of adverse effects of parenteral iron and epoetin alfa 120,000 units given every three weeks [ Time Frame: Patient follow up until week 12 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
|Experimental: Epoetin Alfa plus Iron||
Drug: Epoetin Alfa plus Iron
These injections will take approximately 10-15 minutes to complete. Both will be administered every 3 weeks for a total of 4 cycles, unless the study doctor decides that a change in the amount of Procrit® and iron is necessary once the hemoglobin level rises or is above a certain amount.
In addition to Procrit® and the intravenous iron, the subject will also receive platinum-containing chemotherapy every 3 weeks for 4 cycles as per standard of care for their lung cancer treatment. Radiation therapy will be allowed during this regimen if it is part of the subject's treatment plan.
Other Name: Procrit®; Ferrlecit®
There are more than 170,000 patients diagnosed with lung cancer in the United States each year and many will develop anemia (iron deficiency) during the course of treatment. Anemia is associated with poor quality of life and treatment delays for advanced lung cancer. The treatment of iron deficiency anemia is with iron. Iron is an essential mineral used in red blood cells to carry oxygen throughout the body. Iron is necessary to make hemoglobin, a key element in red blood cells.
The FDA has approved Procrit® (epoetin alfa) to treat anemia in people with non-myeloid (bone marrow) malignancies. Procrit® is a man-made, injectable drug for treating anemia and it encourages red cell production. While the administration of intravenous iron therapy, injected into veins through an IV, did increase the response rate of Procrit® in a previous study, researchers want to find out the best amount of drug to use and the best time to administer Procrit®, along with ferric gluconate, (Ferrlecit®), added for lack of iron.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481624
|United States, Kentucky|
|James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Goetz H Kloecker, MD||James Graham Brown Cancer Center, Univeristy of Louisville|