Clinical trial NCT00661999 (phase 3, 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: sodium ferric gluconate complex in sucrose
SMILES: [O--].[O--].[O--].[Na+].[Fe+3].[Fe+3].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of a non-myeloid cancer (other than non-melanomatous skin cancer)

          -  Receiving or scheduled to receive chemotherapy (biological agents, such as small
             molecules/tyrosine kinase inhibitors and antibody-based therapies, are allowed)

          -  Has chemotherapy-related anemia (hemoglobin < 11 g/dL)

               -  No anemia known to be secondary to gastrointestinal bleeding or hemolysis

               -  No anemia known to be secondary to vitamin B12 or folic acid deficiency

                  + Vitamin B12 and folic acid deficiency must be ruled out if the mean corpuscular
                  volume (MCV) is > 100 fL

               -  No anemia secondary to chemotherapy-induced myelodysplastic syndromes

          -  No primary hematologic disorder causing moderate to severe anemia (e.g., congenital
             dyserythropoietic anemia, homozygous hemoglobin S disease or compound heterozygous
             sickling states, or thalassemia major)

             - Carriers for these disease states are eligible

          -  No first-degree relative with primary hemochromatosis (unless the patient has
             undergone HFE genotyping and was found to have at least one wild-type allele, while
             the proband in the family demonstrated to have either the common C282Y or H63D
             mutation)

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Ferritin > 20 mcg/L (i.e., not obviously iron deficient)

          -  ALT or AST < 5 times upper limit of normal

          -  Alert, mentally competent, and able to sign informed consent

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  Willing or able to be randomized and undergo study treatment

          -  Willing or able to fill out quality-of-life forms

          -  No uncontrolled hypertension (i.e., systolic blood pressure [BP] ≥ 180 mm Hg or
             diastolic BP ≥ 100 mm Hg)

          -  No history of uncontrolled cardiac arrhythmias

          -  No pulmonary embolism or deep venous thrombosis within the past year (unless the
             patient is on anticoagulation therapy and planning to continue it during study
             participation)

          -  No known hypersensitivity to darbepoetin alfa, erythropoietin, mammalian cell-derived
             products, iron, or human albumin

          -  No seizures within the past 3 months

          -  No gastrointestinal conditions expected to cause significant impairment of oral iron,
             such as untreated celiac disease or amyloidosis involving the gut - Patients with
             celiac disease who are adhering to a gluten-free diet are eligible

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 3 months since prior darbepoetin alfa, epoetin alfa, or any investigational
             forms of erythropoietin (e.g., gene-activated erythropoietin or novel
             erythropoiesis-stimulating protein)

          -  More than 1 year since prior peripheral blood stem cell or bone marrow transplantation

          -  More than 2 weeks since prior red blood cell transfusions

          -  More than 14 days since prior major surgery

          -  No prior gastrectomy or resection of > 100 cm of small intestine

          -  Not planning to undergo stem cell or bone marrow transplantation within the next 6
             months