NCT00661999

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2006

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 18, 2011

Completed
Last Updated

May 17, 2011

Status Verified

May 1, 2011

Enrollment Period

3.2 years

First QC Date

April 18, 2008

Results QC Date

February 14, 2011

Last Update Submit

May 13, 2011

Conditions

AnemiaLeukemiaLymphomaLymphoproliferative DisorderMultiple Myeloma and Plasma Cell NeoplasmPrecancerous ConditionUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificmonoclonal gammopathy of undetermined significanceextramedullary plasmacytomaisolated plasmacytoma of bonerefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomaprimary systemic amyloidosisWaldenstrom macroglobulinemiapost-transplant lymphoproliferative disorderstage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromestage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomarecurrent adult grade III lymphomatoid granulomatosisstage I adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult lymphoblastic lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II mantle cell lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomastage I adult diffuse large cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse small cleaved cell lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage I adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage I mantle cell lymphomastage I marginal zone lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaadult acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiarefractory hairy cell leukemiaprogressive hairy cell leukemia, initial treatmentprolymphocytic leukemiaanemiaT-cell large granular lymphocyte leukemiaacute undifferentiated leukemiamast cell leukemiaadult nasal type extranodal NK/T-cell lymphomauntreated hairy cell leukemia

Outcome Measures

Primary Outcomes (1)

  • Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response

    Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb \>= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.

    16 Weeks

Secondary Outcomes (15)

  • Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL

    16 Weeks

  • Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions

    Week 1 to Week 16

  • Mean Increment in Hemoglobin Level at Week 7

    Baseline and 7 weeks

  • Mean Increment in Hemoglobin Level at Week 16

    Baseline and 16 weeks

  • Time to Hematopoietic Response

    16 weeks

  • +10 more secondary outcomes

Study Arms (3)

Arm I

EXPERIMENTAL

Patients receive darbepoetin alfa subcutaneously and sodium ferric gluconate complex IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

Biological: darbepoetin alfaDrug: sodium ferric gluconate complex in sucrose

Arm II

EXPERIMENTAL

Patients receive darbepoetin alfa as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

Biological: darbepoetin alfaDietary Supplement: ferrous sulfate

Arm III

EXPERIMENTAL

Patients receive darbepoetin alfa as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

Biological: darbepoetin alfaOther: placebo

Interventions

darbepoetin alfaBIOLOGICAL

Given by injection

Arm IArm IIArm III
ferrous sulfateDIETARY_SUPPLEMENT

Given by mouth

Arm II
sodium ferric gluconate complex in sucroseDRUG

Given by IV

Arm I
placeboOTHER

Given by mouth

Arm III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

AnemiaLeukemiaLymphomaLymphoproliferative DisordersMultiple MyelomaNeoplasms, Plasma CellPrecancerous ConditionsMonoclonal Gammopathy of Undetermined SignificanceImmunoglobulin Light-chain AmyloidosisWaldenstrom MacroglobulinemiaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeHodgkin DiseaseBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, ProlymphocyticLeukemia, Large Granular LymphocyticLeukemia, Biphenotypic, AcuteLeukemia, Mast-CellLymphoma, Extranodal NK-T-Cell

Interventions

Darbepoetin alfaferrous sulfateferric gluconateSucrose

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersHypergammaglobulinemiaAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLeukemia, LymphoidLymphadenopathyLymphoma, T-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, T-CellLeukemia, Myeloid, AcuteLeukemia, MyeloidMastocytosis, SystemicMastocytosisMast Cell Activation Disorders

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsDisaccharidesOligosaccharidesPolysaccharidesSugars

Results Point of Contact

Title
Dr. Charles L. Loprinzi
Organization
Mayo Clinic Rochester
cloprinzi@mayo.edu
507-284-8666

Study Officials

  • Charles L. Loprinzi, MD

    Mayo Clinic

    STUDY CHAIR

  • Tom R. Fitch, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 21, 2008

Study Start

January 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 17, 2011

Results First Posted

April 18, 2011

Record last verified: 2011-05

Locations

US(2)