Clinical Trial: Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase III, Randomized Study of the Effects of Parenteral Iron, Oral Iron, or No Iron Supplementation on the Erythropoietic Response to Darbepoetin Alfa for Cancer Patients With Chemotherapy-Associat

Brief Summary:

RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.


Detailed Summary:

OBJECTIVES:

Primary

* To compare the effects of IV iron, oral iron, or placebo in combination with darbepoetin alfa on the hematopoietic response rate, defined as a hemoglobin increment of ≥ 2.0 g/dL from baseline or achievement of hemoglobin of ≥ 11 g/dL in the absence of red blood cell transfusions (RBC) in the preceding 28 days of the treatment period, in cancer patients with chemotherapy-associated anemia.

Secondary

  • To compare the effects of these regimens on the mean hemoglobin increment from baseline to weeks 7 and 16 in these patients.
  • To compare the effects of these regimens on the percentage of patients maintaining an average hemoglobin level within the American Society of Hematology/American Society of Clinical Oncology (ASH/ASCO)and National Comprehensive Cancer Network(NCCN) guideline-based target hemoglobin range (11-13 g/dL), once achieving a hemoglobin of ≥ 11 g/dL from week 1 to week 16 in the absence of RBC transfusions in the preceding 28 days of the treatment period.
  • To compare the effects of intravenously (IV) iron, oral iron, or placebo on the response to darbepoetin alfa, in terms of time to achieving hemoglobin levels of ≥ 11g/dL.
  • To compare the effects of these regimens on the percentage of patients who require RBC transfusions and the total transfusion needs.
  • To compare the effects of these regimens on the change in hemoglobin week by week.
  • To compare the effects of these regimens on quality-of-life changes from baseline to weeks 7 and 16.
  • Sponsor: Mayo Clinic

    Current Primary Outcome: Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response [ Time Frame: 16 Weeks ]

    Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.


    Original Primary Outcome: Proportion of patients who exhibit a hematopoietic response

    Current Secondary Outcome:

    • Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL [ Time Frame: 16 Weeks ]
    • Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions [ Time Frame: Week 1 to Week 16 ]
    • Mean Increment in Hemoglobin Level at Week 7 [ Time Frame: Baseline and 7 weeks ]
      Value at 7 weeks minus value at baseline.
    • Mean Increment in Hemoglobin Level at Week 16 [ Time Frame: Baseline and 16 weeks ]
      Value at 16 weeks minus value at baseline.
    • Time to Hematopoietic Response [ Time Frame: 16 weeks ]
      Hematopoietic response was defined as Hb increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.
    • Time to First Red Blood Cell (RBC) Transfusions [ Time Frame: 16 weeks ]
    • Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA) [ Time Frame: Baseline and 16 weeks ]
      Overall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline.
    • Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study [ Time Frame: Baseline and 16 weeks ]
      SDS Scale range: 0 (Worst), 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.
    • Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study [ Time Frame: Baseline and 16 weeks ]
      Fatigue Now Scale range: 0 (No Fatigue) to 10 (Worst), ordinal. Change: score at 16 weeks minus score at baseline.
    • Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study [ Time Frame: Baseline and 16 weeks ]
      FACT-AN Scale range: 0 (Worst) to 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.
    • C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16 [ Time Frame: 1 Week, 7 Weeks and 16 Weeks ]
    • Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16 [ Time Frame: 1 week, 7 weeks and 16 weeks ]
    • Ferritin Level at Baseline, Week 7 and Week 16 [ Time Frame: Baseline, 7 weeks and 16 weeks ]
    • Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16 [ Time Frame: Baseline, 7 weeks and 16 weeks ]
      MCV is a measure of the average red blood cell volume.
    • Transferrin Saturation at Baseline, Week 7 and Week 16 [ Time Frame: Baseline, 7 weeks and 16 weeks ]


    Original Secondary Outcome:

    • Percentage of patients maintaining an average hemoglobin level within the NCCN range (11-13 g/dL) through week 16, once achieving a hemoglobin of ≥ 11 g/dL
    • Incidence of patients receiving at least one RBC transfusion from week 1 to week 16
    • Comparison of mean hemoglobin increment at weeks 7 and 16 with the baseline hemoglobin value
    • Time to hematopoietic response
    • Time to first RBC transfusion
    • Overall quality of life as measured by the UNISCALE, LASA, SDS, BFI, and FACT-An questionnaires
    • Effect of CRP, serum hepcidin levels, sTfR/log ferritin ratio, ferritin, MCV, red cell distribution width, and transferrin saturation on response rates


    Information By: Mayo Clinic

    Dates:
    Date Received: April 18, 2008
    Date Started: January 2006
    Date Completion:
    Last Updated: May 13, 2011
    Last Verified: May 2011