Clinical Trial: Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy

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

Official Title: RC05CB A Pilot, Randomized Comparison of Standard Weekly Epoetin Alfa to Every-3-Week-Epoetin Alfa and Every 3-Week Darbepoetin Alfa

Brief Summary:

RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with cancer.

PURPOSE: This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with anemia caused by chemotherapy.


Detailed Summary:

OBJECTIVES:

Primary

  • Compare the relative efficacy of four different erythropoietic agent dosing schedules comprising epoetin alfa or darbepoetin alfa, in terms of the proportion of patients with chemotherapy-associated anemia who achieve a weekly and overall hematopoietic response.

Secondary

  • Compare the effect of these regimens on the mean hemoglobin increment measured weekly from baseline to 15 weeks in patients with a baseline hemoglobin of less than or equal to 10.5 g/dL.
  • Compare the time required to achieve hemoglobin levels within the goal range 11.0-12.0 g/dL in patients treated with these regimens.
  • Compare the effect of these regimens on the proportion of patients requiring red blood cell transfusions and on the number of transfusions required.
  • Compare the weekly change in hemoglobin in patients treated with these regimens.
  • Compare the need for dose reduction in patients treated with these regimens.
  • Compare the adverse event profiles of these regimens in these patients.
  • Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, unblinded, pilot study. Patients are stratified according to severity of anemia (mild [hemoglobin ≥ 9.5 g/dL] vs severe [hemoglobin < 9.5 g/dL]), platinum-containing regimen (yes vs no), and tumor type (nonmyeloid hematologic malignancy vs solid tumor). Patients are randomized to 1 of 4 treatment arms.

    A hematopoietic response was defined as Hb rise >2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period


Original Primary Outcome: Hematopoietic response (hemoglobin rise of 2 g/dL from baseline OR achievement of hemoglobin of at least 12 g/dL)

Current Secondary Outcome:

  • Weekly Change in Hemoglobin Levels [ Time Frame: Baseline and Week 4, 7, 10, 13, 16 ]
    To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule
  • Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL [ Time Frame: 16 weeks ]
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
  • Mean Hemoglobin Change From Week 1 to Week 16 [ Time Frame: Week 1 and Week 16 ]
    To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule. The positive numbers represent hemoglobin increases and negative numbers represent hemoglobin decreases.
  • The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions [ Time Frame: 16 weeks ]
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
  • The Total RBC Transfusion Needed [ Time Frame: 16 weeks ]
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
  • The Percentage of Participants With Dose Omitted Due to Hematologic Reason [ Time Frame: 16 Weeks ]
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
  • The Percentage of Participants Reported Grade 3 or 4 Adverse Events [ Time Frame: 16 weeks ]
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Adverse events were measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
  • Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations [ Time Frame: Weeks 4, 7, 10, 13 and 16 ]
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. FACT-AN consist of Fatigue concerns subscale and non-fatigue concerns subscale. FACT Total Anemia score was calculated by adding the two subscales scores and transformed into 0-100 scale. FACT Total Anemia, Fatigue concerns scale and Non-Fatigue concerns scale are all ranges: 0 (Worst QOL) to 100 (Best QOL). Average scores across all time points for each subscale and total scale were calculated.
  • Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation [ Time Frame: Weeks 4, 7, 10, 13 and 16 ]
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Linear Analogue Self Assessment (LASA) consists of 10 single-item numeric analogue scales on a scale of 0 to 10. Higher scores indicate better quality of life (QOL) on overall QOL, mental, physical, emotional spiritual QOL and Social activity; and constant pain, highest pain severity, level of fatigue and anxiety. Average scores across all time points for each item were calculated.
  • Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations [ Time Frame: Weeks 4, 7, 10, 13 and 16 ]
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Brief Fatigue Inventory (BFI) consist of 3 single-item numeric analogue scales on a scale of 0 to 10; and an interference scale formed by 6 single-item numeric scales on a scale of 0 to 10. Higher scores indicate fatigue as bad as you can imagine for fatigue now, usual fatigue and worse fatigue; and completely interferes for BFI interference. Average scores across all time points for fatigue now, usual fatigue, worst fatigue and BFI interference subscale were calculated.
  • Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations [ Time Frame: Weeks 4, 7, 10, 13 and 16 ]
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. SDS Scale range: 1 (No Symptom), 5 (Worst Symptom). Average scores across all time points for each item were calculated.


Original Secondary Outcome:

  • Weekly Change in Hemoglobin Levels
  • Hemoglobin changes from baseline to weeks 4, 7, 10, 13, and 16
  • Time required to achieve hemoglobin levels of at least 12.0 g/dL
  • Proportion of patients requiring red blood cell (RBC) transfusions and the number of transfusions required
  • Dose reduction in each regimen
  • Adverse events as measured by CTCAE v3.0
  • Quality of life as measured by Functional Assessment of Cancer Therapy Scales for Anemia, Linear Analogue Self Assessment measures, Brief Fatigue Inventory, and Symptom Distress Scale at baseline and at 4, 8, 16, and 24 weeks


Information By: Mayo Clinic

Dates:
Date Received: December 27, 2006
Date Started: May 2007
Date Completion:
Last Updated: December 19, 2016
Last Verified: September 2015