NCT00661999 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2011-05-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Mean Increment in Hemoglobin Level at Week 7

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outcome · POSTED

Mean Increment in Hemoglobin Level at Week 16

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outcome · POSTED

Time to Hematopoietic Response

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outcome · POSTED

Time to First Red Blood Cell (RBC) Transfusions

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outcome · POSTED

Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)

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outcome · POSTED

Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study

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outcome · POSTED

Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study

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outcome · POSTED

Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study

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outcome · POSTED

C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16

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outcome · POSTED

Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16

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outcome · POSTED

Ferritin Level at Baseline, Week 7 and Week 16

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outcome · POSTED

Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16

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outcome · POSTED

Transferrin Saturation at Baseline, Week 7 and Week 16

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Biological: darbepoetin alfa
Drug: sodium ferric gluconate complex in sucrose
label
Arm I
type
EXPERIMENTAL
description
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.
intervention Names
Biological: darbepoetin alfa
Dietary Supplement: ferrous sulfate
label
Arm II
type
EXPERIMENTAL
description
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.
intervention Names
Biological: darbepoetin alfa
Other: placebo
label
Arm III
type
EXPERIMENTAL

interventions

arm Group Labels
Arm I
Arm II
Arm III
description
Given by injection
name
darbepoetin alfa
type
BIOLOGICAL
arm Group Labels
Arm II
description
Given by mouth
name
ferrous sulfate
type
DIETARY_SUPPLEMENT
arm Group Labels
Arm I
description
Given by IV
name
sodium ferric gluconate complex in sucrose
type
DRUG
arm Group Labels
Arm III
description
Given by mouth
name
placebo
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE
who Masked: PARTICIPANT
INVESTIGATOR

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 502
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response
time Frame
16 Weeks

secondary Outcomes

measure
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
time Frame
16 Weeks
measure
Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions
time Frame
Week 1 to Week 16
description
Value at 7 weeks minus value at baseline.
measure
Mean Increment in Hemoglobin Level at Week 7
time Frame
Baseline and 7 weeks
description
Value at 16 weeks minus value at baseline.
measure
Mean Increment in Hemoglobin Level at Week 16
time Frame
Baseline and 16 weeks
description
Hematopoietic response was defined as 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.
measure
Time to Hematopoietic Response
time Frame
16 weeks
measure
Time to First Red Blood Cell (RBC) Transfusions
time Frame
16 weeks
description
Overall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline.
measure
Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)
time Frame
Baseline and 16 weeks
description
SDS Scale range: 0 (Worst), 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.
measure
Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study
time Frame
Baseline and 16 weeks
description
Fatigue Now Scale range: 0 (No Fatigue) to 10 (Worst), ordinal. Change: score at 16 weeks minus score at baseline.
measure
Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study
time Frame
Baseline and 16 weeks
description
FACT-AN Scale range: 0 (Worst) to 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.
measure
Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study
time Frame
Baseline and 16 weeks
measure
C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16
time Frame
1 Week, 7 Weeks and 16 Weeks
measure
Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16
time Frame
1 week, 7 weeks and 16 weeks

Full study description

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.
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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice