Efficacy of Ferric Carboxymaltose in Gastrointestinal Stromal Tumor (GIST) Patients With Iron Deficiency Anemia (IDA) Receiving Systemic Therapy
Condition: Malignant Neoplasms of Mesothelial and Soft Tissue; Gastrointestinal Stromal Tumor With Neurogenic Differentiation
MeSH terms: Neoplasms; Gastrointestinal Stromal Tumors; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferric Carboxymaltose; Iron Supplements; Questionnaire
Intervention description: 15 mg/kg by vein (up to 750 mg) over 15 min infusion. Dose repeated 1 week later.; Participants take iron supplements by mouth every day for up to 3 months.; Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Malignant Neoplasms of Mesothelial and Soft Tissue; Gastrointestinal Stromal Tumor; GIST; Iron-deficiency anemia; Ferric Carboxymaltose; Injectafer; Iron supplement; Health Questionnaire; Survey

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. GIST patients with IDA planned to start or are receiving systemic therapy with TKIs.

          2. Evidence of iron deficiency anemia including, Hgb < 11 g/dL, but > 8 g/dL; and
             transferrin saturation (TSAT) < 20%.

          3. No H/O allergic reaction to iron therapy.

          4. No clinical signs active of bleeding.

          5. Adequate hematologic (ANC > 1500/mm^3, platelet count > 100,000/mm^3), renal (serum
             creatinine < 1.5mg/dL), and hepatic (serum bilirubin count < 1.5 x normal and serum
             glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT)
             < 3 x normal) functions.

          6. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 -
             2.

          7. Signed informed consent to the study.

          8. Male and Females of child bearing potential must use acceptable methods of birth
             control which include oral contraceptives, spermicide with either a condom, diaphragm
             or cervical cap, use of an intrauterine device (IUD) or abstinence.

          9. Patients are required to read and understand English to comply with protocol
             requirements.

         10. Age >=18 years old.

         11. Life expectancy of at least 6 months.

        Exclusion Criteria:

          1. Pregnant or lactating women.

          2. Patients with any co-morbid condition which renders patients at high risk of treatment
             complication.

          3. Patient has uncontrolled angina, congestive heart failure (New York Heart Association
             > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia or
             hypertension, or acute myocardial infarction within 3 months.

          4. Patient has an active seizure disorder. (Patients with a previous history of seizure
             disorders will be eligible for the study, if they have had no evidence of seizure
             activity, and they have been free of antiseizure medication for the previous 5 years).

          5. Psychological, social, familial, or geographical reasons that would prevent scheduled
             visits and follow-up.

          6. Prior surgery or radiotherapy (RT) within 2 weeks of study entry.

          7. Known hypersensitivity reaction to any component of ferric carboxymaltose.

          8. Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, or
             erythropoiesis-stimulating agents), or transfusion of PRBCs in 2 weeks.

          9. Hemochromatosis or other iron storage disorders.

         10. Known positive hepatitis with evidence of active disease.

         11. Patients with overt bleeding.

         12. Ferritin >/= 800 ng/mL.