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

Brief Summary

Detailed Description

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.

Primary Outcomes

Secondary Outcomes

• Weekly Change in Hemoglobin Levels(Baseline and Week 4, 7, 10, 13, 16)
• Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL(16 weeks)
• Mean Hemoglobin Change From Week 1 to Week 16(Week 1 and Week 16)
• The Total RBC Transfusion Needed(16 weeks)
• The Percentage of Participants Reported Grade 3 or 4 Adverse Events(16 weeks)
• The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions(16 weeks)
• The Percentage of Participants With Dose Omitted Due to Hematologic Reason(16 Weeks)
• Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations(Weeks 4, 7, 10, 13 and 16)
• Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations(Weeks 4, 7, 10, 13 and 16)
• Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation(Weeks 4, 7, 10, 13 and 16)
• Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations(Weeks 4, 7, 10, 13 and 16)