Clinical trial NCT00416624 (phase 2, status: completed)
Conditions: anemia, leukemia, lymphoma, lymphoproliferative disorder, multiple myeloma and plasma cell neoplasm, precancerous condition, unspecified adult solid tumor, protocol specific
ICD codes: D53.2, D64.9, D46.4, D53.0, D53.9, D61.3, D61.9, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, D47.Z1, C96.20, C96.29, D47.09, Y95, D69.9, J94.9, L53.9, G47.01, G47.14, P28.9, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: darbepoetin alfa, epoetin alfa
SMILES: OC(=O)CNC(=O)C1C(=O)N(C2CCCCC2)C(=O)N(C2CCCCC2)C1=O
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)