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Phase 2 Completed N=236 Randomized Supportive Care

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

Anemia · leukemia · Lymphoma · Lymphoproliferative Disorder
Source: ClinicalTrials.gov NCT00416624 ↗
Enrolled (actual)
236
Serious AEs
7.3%
Results posted
Feb 2017
Primary outcomePrimary: The Percentage of Participants Who Exhibit a Hematopoietic Response — 68.9; 61.7; 65.5; 66.7 Percentage of participants — p=>0.41

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
The Percentage of Participants Who Exhibit a Hematopoietic Response
68.9; 61.7; 65.5; 66.7 >0.41
SECONDARY
Weekly Change in Hemoglobin Levels
1.0; 0.6; 0.7; 0.4; 1.7; 1.0
SECONDARY
Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL
32; 50; 49; 49 >0.13
SECONDARY
Mean Hemoglobin Change From Week 1 to Week 16
11.0; 10.3; 10.6; 10.7
SECONDARY
The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions
27.9; 33.3; 22.4; 29.8 >0.49
SECONDARY
The Total RBC Transfusion Needed
1.1; 1.2; 0.6; 1.1
SECONDARY
The Percentage of Participants With Dose Omitted Due to Hematologic Reason
63.9; 30; 34.5; 45.6
SECONDARY
The Percentage of Participants Reported Grade 3 or 4 Adverse Events
22; 22; 17; 13 >0.56
SECONDARY
Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations
48.6; 52.0; 52.6; 49.8; 60.6; 62.2
SECONDARY
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
6.4; 6.5; 6.6; 6.1; 6.9; 7.0
SECONDARY
Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations
4.8; 4.6; 4.6; 4.7; 4.7; 4.7
SECONDARY
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
1.6; 1.5; 1.6; 1.6; 1.5; 1.4

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of solid tumor or nonmyeloid hematologic malignancy (e.g., plasma cell dyscrasia or lymphoproliferative disorder)
  • No nonmelanomatous skin cancer
  • Hemoglobin ≤ 10.5 g/dL
  • Ferritin > 20 ng/mL (i.e., not obviously iron deficient)
  • Planning to receive ≥ 12 weeks of anticancer chemotherapy
  • Biological therapy (e.g., hypomethylating agents, monoclonal antibodies, or small molecule pathway inhibitors) with an individual or cumulative regimen incidence of grade 3 or 4 anemia > 10% is considered chemotherapy for purposes of this study
  • No known anemia secondary to any of the following:
  • Cyanocobalamin (vitamin B\_12) or folic acid deficiency
  • Gastrointestinal bleeding within the past 2 weeks
  • Hemolysis
  • Myelodysplastic syndromes, myeloproliferative disorders, or acute myeloid leukemia
  • No primary hematologic disorder causing chronic moderate to severe anemia (e.g., congenital dyserythropoietic anemia, homozygous hemoglobin S disease or compound heterozygous sickling states, or thalassemia major)
  • Carriers of these disease states allowed provided they are not anemic prior to cancer diagnosis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
  • Not pregnant or nursing
  • No delivery of a baby of ≥ 18 weeks estimated gestational age within the past 3 months (90 days)
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Weight > 40.0 kg and < 150.0 kg
  • No known hypersensitivity to epoetin alfa, darbepoetin alfa, mammalian-cell derived products, or human albumin
  • No uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 180 mm Hg and/or diastolic BP ≥ 100 mm Hg, despite medical therapy
  • No pulmonary emboli and/or deep vein thrombosis within the past 12 months
  • Patients actively receiving warfarin for a minimum of 4 weeks are exempted from this requirement
  • Prior superficial thrombophlebitis allowed
  • No cerebrovascular accident, ischemic stroke, acute coronary syndrome (e.g., unstable angina or Q-wave or non-Q wave myocardial infarction), or other arterial or venous thrombotic events within the past 6 months
  • No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)
  • Patients receiving anticoagulation therapy (warfarin or acetylsalicyclic acid [aspirin] at a dose of ≥ 325 mg/day) for these conditions are eligible provided therapy is continued during the study period
  • History of previously treated seizures allowed provided the patient has been seizure-free for a minimum of 3 months

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 1 year since prior peripheral blood stem cell, bone marrow, or cord blood transplantation
  • More than 14 days since prior red blood cell transfusion
  • More than 14 days since prior major surgery, including, but not limited to, any of the following:
  • Amputation
  • Invasion of a body cavity or of the central nervous system using a scalpel, saw, or laser cutting tool
  • Resection of a body part (or parts), whether solid or liquid tissue or both, that includes ≥ 1% of a patient's preoperative weight
  • The following are not considered major surgery:
  • Diagnostic/therapeutic thoracentesis or paracentesis
  • Diagnostic skin biopsy
  • Digit or fingernail/thumbnail resection or laceration repair under local anesthesia
  • Diagnostic fat aspiration
  • Otic irrigation to remove cerumen impaction
  • Tympanocentesis
  • Uncomplicated dental extraction
  • Uncomplicated tonsillectomy
  • Laser corneal remodeling for refraction purposes
  • Cosmetic or therapeutic eyelid surgery
  • Bone marrow aspiration and biopsy
  • More than 10 weeks since prior darbepoetin alfa, epoetin alfa, or any investigational form of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis stimulating protein)
  • No planned stem cell transplantation within the next 4 months (18 weeks)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00416624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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