Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer

You may be eligible if

• 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