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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Darbepoetin alfa; Ferric Compounds; Ferric gluconate

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