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

Inclusion 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)