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

• Hematopoietic response (hemoglobin rise of 2 g/dL from baseline OR achievement of hemoglobin within the goal range) [ Time Frame: 20 weeks ]
  the proportion of patients who exhibit a hematopoietic response (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
  
  

• Weekly change in hemoglobin levels [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa
  
  
• Time required to achieve hemoglobin levels within the goal range [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa
  
  
• Proportion of patients requiring red blood cell (RBC) transfusions and the number of transfusions required [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa
  
  
• Dose reduction in each regimen [ Designated as safety issue: No ]
  To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa
  
  
• Adverse events as measured by CTCAE v3.0 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa
  
  
• 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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa
  
  
• Mean hemoglobin increment week by week [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa
  
  

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.

• Arm I: Patients receive epoetin alfa subcutaneously (SC) on day 1. Treatment repeats weekly for up to 15 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm I). Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.
• Arm III: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm II). Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.
• Arm IV: Patients receive darbepoetin alfa SC on day 1. Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.

Hemoglobin levels are monitored throughout the study on a weekly basis and before each drug dose is administered. Drug dosing is adjusted (e.g., held, reduced, resumed at a lower dose) as needed to maintain hemoglobin values within the desired ranges.

Quality of life is assessed at baseline and at weeks 4, 7, 10, 13, and 16.

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study.