Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy
Condition: Anemia; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Precancerous Conditions; Anemia; Lymphoproliferative Disorders
Intervention: darbepoetin alfa; epoetin alfa; fatigue assessment and management; quality-of-life assessment
Intervention MeSH terms: Epoetin Alfa; Darbepoetin alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: unspecified adult solid tumor, protocol specific; extramedullary plasmacytoma; isolated plasmacytoma of bone; refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; Waldenstrom macroglobulinemia; post-transplant lymphoproliferative disorder; stage I adult T-cell leukemia/lymphoma; stage II adult T-cell leukemia/lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma; recurrent adult T-cell leukemia/lymphoma; AIDS-related peripheral/systemic lymphoma; AIDS-related primary CNS lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; recurrent mycosis fungoides/Sezary syndrome; stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; recurrent adult Hodgkin lymphoma; adult grade III lymphomatoid granulomatosis; stage I adult Burkitt lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma; noncontiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II mantle cell lymphoma; noncontiguous stage II marginal zone lymphoma; noncontiguous stage II small lymphocytic lymphoma; contiguous stage II adult Burkitt lymphoma; contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult diffuse small cleaved cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult lymphoblastic lymphoma; contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II mantle cell lymphoma; contiguous stage II marginal zone lymphoma; contiguous stage II small lymphocytic lymphoma; stage I adult diffuse large cell lymphoma; stage I adult diffuse mixed cell lymphoma; stage I adult diffuse small cleaved cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage I adult lymphoblastic lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage I grade 3 follicular lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage I mantle cell lymphoma; stage I marginal zone lymphoma; stage III mantle cell lymphoma; stage III marginal zone lymphoma; stage IV mantle cell lymphoma; stage IV marginal zone lymphoma; stage I small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; recurrent adult Burkitt lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult grade III lymphomatoid granulomatosis; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; adult acute lymphoblastic leukemia in remission; recurrent adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; refractory chronic lymphocytic leukemia; refractory hairy cell leukemia; progressive hairy cell leukemia, initial treatment; prolymphocytic leukemia; anemia; monoclonal gammopathy of undetermined significance; primary systemic amyloidosis; T-cell large granular lymphocyte leukemia; acute undifferentiated leukemia; mast cell leukemia; adult nasal type extranodal NK/T-cell lymphoma; untreated hairy cell leukemia

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.
    

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)