Trials / Completed

CompletedNCT00661999

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

A Phase III, Randomized Study of the Effects of Parenteral Iron, Oral Iron, or No Iron Supplementation on the Erythropoietic Response to Darbepoetin Alfa for Cancer Patients With Chemotherapy-Associated Anemia

Status: Completed
Phase: Phase 3
Study type: Interventional
Enrollment: 502 (actual)

Sponsor: Mayo Clinic · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary \* To compare the effects of IV iron, oral iron, or placebo in combination with darbepoetin alfa on the hematopoietic response rate, defined as a hemoglobin increment of ≥ 2.0 g/dL from baseline or achievement of hemoglobin of ≥ 11 g/dL in the absence of red blood cell transfusions (RBC) in the preceding 28 days of the treatment period, in cancer patients with chemotherapy-associated anemia. Secondary * To compare the effects of these regimens on the mean hemoglobin increment from baseline to weeks 7 and 16 in these patients. * To compare the effects of these regimens on the percentage of patients maintaining an average hemoglobin level within the American Society of Hematology/American Society of Clinical Oncology (ASH/ASCO)and National Comprehensive Cancer Network(NCCN) guideline-based target hemoglobin range (11-13 g/dL), once achieving a hemoglobin of ≥ 11 g/dL from week 1 to week 16 in the absence of RBC transfusions in the preceding 28 days of the treatment period. * To compare the effects of intravenously (IV) iron, oral iron, or placebo on the response to darbepoetin alfa, in terms of time to achieving hemoglobin levels of ≥ 11g/dL. * To compare the effects of these regimens on the percentage of patients who require RBC transfusions and the total transfusion needs. * To compare the effects of these regimens on the change in hemoglobin week by week. * To compare the effects of these regimens on quality-of-life changes from baseline to weeks 7 and 16. * To identify if patients with inflammation (as indicated by elevated C-reactive protein (CRP) and serum hepcidin levels or low soluble transferrin receptor (sTfR)/log ferritin ratios) respond differently to darbepoetin alfa and iron therapy than patients without inflammation. OUTLINE: Patients are stratified according to severity of anemia (mild \[hemoglobin ≥ 9.5 g/dL\] vs severe \[hemoglobin \< 9.5 g/dL\]), treatment with a platinum-containing regimen (yes vs no), and gender. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive darbepoetin alfa subcutaneously and sodium ferric gluconate complex IV over 90 minutes on day 1. * Arm II: Patients receive darbepoetin alfa as in arm I and oral ferrous sulfate once daily on days 1-21. * Arm III: Patients receive darbepoetin alfa as in arm I and oral placebo once daily on days 1-21. In all arms, treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. Patients complete quality-of-life (QOL) questionnaires in weeks 1, 7, and 16.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	darbepoetin alfa	Given by injection
DIETARY_SUPPLEMENT	ferrous sulfate	Given by mouth
DRUG	sodium ferric gluconate complex in sucrose	Given by IV
OTHER	placebo	Given by mouth

Timeline

Start date: 2006-01-01
Primary completion: 2009-03-01
Completion: 2009-03-01
First posted: 2008-04-21
Last updated: 2011-05-17
Results posted: 2011-04-18

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00661999. Inclusion in this directory is not an endorsement.