Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Anemia

Intervention / Treatment
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* Drug: Epoetin Alfa plus Iron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed small cell or non small cell lung cancer Stage III or Stage IV lung cancer Platinum containing chemotherapy induced anemia (< 10 g/dl Hb) Cancer related anemia (<10 g/dl Hb) at time of initiation of chemotherapy ECOG performance status of 0,1, or 2 Informed consent Age>18 Expected to receive platinum based outpatient chemotherapy for at least nine weeks Exclusion Criteria: Pregnant women Intolerance to epoetin alfa or parenteral iron More than 2 cycles of the planned platinum chemotherapy at time of enrollment Chronic GI bleed (> than 4 weeks positive hemoccult or gastroccult) Ferritin > 500 mg/dl Anemia due to other causes than cancer or chemotherapy Previous parenteral iron therapy Uncontrolled hypertension (systolic BP > 160, diastolic > 100 mmHg)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epoetin Alfa plus Iron<br> | Drug: Epoetin Alfa plus Iron<br>* One (1) injection of Procrit®, by needle, inserted just under the skin; 125 mg of ferric gluconate (an iron injection product), through an IV injection into a vein. 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.<br>* Other names: Procrit®; Ferrlecit®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieve hemoglobin responses > 2g/dl in at least 70% of patients |  | Nine weeks, after at least two doses of 120,000 units epoetin alfa | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive evaluation of adverse effects of parenteral iron and epoetin alfa 120,000 units given every three weeks |  | Patient follow up until week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced lung cancer, Procrit, Epoetin Alfa, Ferric Gluconate, iron supplementation