Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia
| Status: | Withdrawn |
|---|---|
| Conditions: | Lung Cancer, Anemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | May 2007 |
| End Date: | November 2009 |
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
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.
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.
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.
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.
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)
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