Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
James Graham Brown Cancer Center |
---|---|
Information provided by: | James Graham Brown Cancer Center |
ClinicalTrials.gov Identifier: | NCT00481624 |
The purpose of this study is to find a better, more convenient way to improve anemia results by increasing the amount of medication given at 3 week intervals. Researchers want to know if giving a higher dose of Procrit® and intravenous (IV) iron once every 3 weeks would give better results in treating anemia without the need for more office visits.
Condition | Intervention | Phase |
---|---|---|
Advanced Lung Cancer Chemotherapy Induced Anemia |
Drug: Epoetin Alfa plus Iron |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 25 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | James Graham Brown Cancer Center ( Goetz H. Kloecker, MD ) |
Study ID Numbers: | 210.07 |
Study First Received: | June 1, 2007 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00481624 |
Health Authority: | United States: Institutional Review Board |
advanced lung cancer Procrit Epoetin Alfa Ferric Gluconate iron supplementation |
Epoetin Alfa Thoracic Neoplasms Respiratory Tract Diseases Hematologic Diseases Lung Neoplasms |
Lung Diseases Ferric gluconate Anemia Iron |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Hematinics Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Hematologic Agents Trace Elements Micronutrients Pharmacologic Actions |