Malignant Neoplasms of Mesothelial and Soft Tissue Clinical Trial
Official title:
Efficacy of Ferric Carboxymaltose in Gastrointestinal Stromal Tumor (GIST) Patients With Iron Deficiency Anemia (IDA) Receiving Systemic Therapy
The goal of this clinical research study is to compare Injectafer® (ferric carboxymaltose)
with an iron supplement to learn which may be more effective in improving red blood cell
counts in patients who have iron-deficiency anemia (a low red blood cell count) because of a
gastrointestinal stromal tumor (GIST) and/or systemic therapy.
The safety of ferric carboxymaltose will also be studied.
This is an investigational study. Ferric carboxymaltose is FDA approved and commercially
available to treat iron deficiency anemia; however, it is considered investigational to use
in patients who have cancer-related or systemic therapy-related anemia.
Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned (as
in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one group
is better, the same, or worse than the other.
- If you are in Group A, you will receive ferric carboxymaltose injection by vein over
about 15 minutes. You will receive 2 injections about 7 days apart (for example, on Days
0 [the day you are assigned to a study group] and 7).
- If you are in Group B, you will take iron supplements by mouth every day. This is
considered standard of care for iron deficiency anemia and the study staff will discuss
with you which iron supplements you will take and their risks.
You and the study staff will know to which group you are assigned.
Length of Study:
You may receive up to 2 injections of ferric carboxymaltose (if you are in Group A) or up to
3 months of oral iron supplements (if you are in Group B). You will no longer be able to take
the study drug if intolerable side effects occur or if you are unable to follow study
directions.
Your participation on the study will be over after you have completed the Week 24 visit.
Study Visits:
Baseline (within 1 week after you have been assigned to a study group):
- You will have a physical exam.
- You will complete a questionnaire about your health. It should take about 5 minutes to
complete.
- Blood (about 1 tablespoon) will be drawn for routine tests and to test the level of iron
in your blood.
One (1) time every week during Months 1-3, blood (about 1 tablespoon) will be drawn for
routine tests.
At about Weeks 4, 8, 12, and 24 (the end-of-study visit):
- You will have a physical exam (Weeks 12 and 24 only).
- You will complete the same questionnaire you did at baseline.
- Blood (about 1 tablespoon) will be drawn for routine tests and to test the level of iron
in your blood.
During Weeks 16 and 20, blood (less than 1 tablespoon) will be drawn to test the level of
iron in your blood.
If you leave the study before Week 24, you will have the Week 24 study visits as soon as
possible after you leave the study.
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