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NCT00416624 · REGISTRY CONDITION SEARCH

Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy

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

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-02-10

RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with cancer. PURPOSE: This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with anemia caused by chemotherapy.

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

The Percentage of Participants Who Exhibit a Hematopoietic Response

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outcome · POSTED

Weekly Change in Hemoglobin Levels

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outcome · POSTED

Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL

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outcome · POSTED

Mean Hemoglobin Change From Week 1 to Week 16

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outcome · POSTED

The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions

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outcome · POSTED

The Total RBC Transfusion Needed

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outcome · POSTED

The Percentage of Participants With Dose Omitted Due to Hematologic Reason

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outcome · POSTED

The Percentage of Participants Reported Grade 3 or 4 Adverse Events

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outcome · POSTED

Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations

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outcome · POSTED

Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation

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outcome · POSTED

Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations

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outcome · POSTED

Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations

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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 solid tumor or nonmyeloid hematologic malignancy (e.g., plasma cell dyscrasia or lymphoproliferative disorder) * No nonmelanomatous skin cancer * Hemoglobin ≤ 10.5 g/dL * Ferritin \> 20 ng/mL (i.e., not obviously iron deficient) * Planning to receive ≥ 12 weeks of anticancer chemotherapy * Biological therapy (e.g., hypomethylating agents, monoclonal antibodies, or small molecule pathway inhibitors) with an individual or cumulative regimen incidence of grade 3 or 4 anemia \> 10% is considered chemotherapy for purposes of this study * No known anemia secondary to any of the following: * Cyanocobalamin (vitamin B\_12) or folic acid deficiency * Gastrointestinal bleeding within the past 2 weeks * Hemolysis * Myelodysplastic syndromes, myeloproliferative disorders, or acute myeloid leukemia * No primary hematologic disorder causing chronic moderate to severe anemia (e.g., congenital dyserythropoietic anemia, homozygous hemoglobin S disease or compound heterozygous sickling states, or thalassemia major) * Carriers of these disease states allowed provided they are not anemic prior to cancer diagnosis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 6 months * Not pregnant or nursing * No delivery of a baby of ≥ 18 weeks estimated gestational age within the past 3 months (90 days) * Negative pregnancy test * Fertile patients must use effective contraception * Weight \> 40.0 kg and \< 150.0 kg * No known hypersensitivity to epoetin alfa, darbepoetin alfa, mammalian-cell derived products, or human albumin * No uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 180 mm Hg and/or diastolic BP ≥ 100 mm Hg, despite medical therapy * No pulmonary emboli and/or deep vein thrombosis within the past 12 months * Patients actively receiving warfarin for a minimum of 4 weeks are exempted from this requirement * Prior superficial thrombophlebitis allowed * No cerebrovascular accident, ischemic stroke, acute coronary syndrome (e.g., unstable angina or Q-wave or non-Q wave myocardial infarction), or other arterial or venous thrombotic events within the past 6 months * No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency) * Patients receiving anticoagulation therapy (warfarin or acetylsalicyclic acid \[aspirin\] at a dose of ≥ 325 mg/day) for these conditions are eligible provided therapy is continued during the study period * History of previously treated seizures allowed provided the patient has been seizure-free for a minimum of 3 months PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 1 year since prior peripheral blood stem cell, bone marrow, or cord blood transplantation * More than 14 days since prior red blood cell transfusion * More than 14 days since prior major surgery, including, but not limited to, any of the following: * Amputation * Invasion of a body cavity or of the central nervous system using a scalpel, saw, or laser cutting tool * Resection of a body part (or parts), whether solid or liquid tissue or both, that includes ≥ 1% of a patient's preoperative weight * The following are not considered major surgery: * Diagnostic/therapeutic thoracentesis or paracentesis * Diagnostic skin biopsy * Digit or fingernail/thumbnail resection or laceration repair under local anesthesia * Diagnostic fat aspiration * Otic irrigation to remove cerumen impaction * Tympanocentesis * Uncomplicated dental extraction * Uncomplicated tonsillectomy * Laser corneal remodeling for refraction purposes * Cosmetic or therapeutic eyelid surgery * Bone marrow aspiration and biopsy * More than 10 weeks since prior darbepoetin alfa, epoetin alfa, or any investigational form of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis stimulating protein) * No planned stem cell transplantation within the next 4 months (18 weeks)
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    40,000 Units
    intervention Names
    1. Drug: darbepoetin alfa
    2. Drug: epoetin alfa
    3. Procedure: fatigue assessment and management
    4. Procedure: quality-of-life assessment
    label
    Epoetin alfa - 40000 units
    type
    EXPERIMENTAL
  2. description
    80,000 Units
    intervention Names
    1. Drug: darbepoetin alfa
    2. Drug: epoetin alfa
    3. Procedure: fatigue assessment and management
    4. Procedure: quality-of-life assessment
    label
    Epoetin alfa - 80000 units
    type
    EXPERIMENTAL
  3. description
    120,000 Units
    intervention Names
    1. Drug: darbepoetin alfa
    2. Drug: epoetin alfa
    3. Procedure: fatigue assessment and management
    4. Procedure: quality-of-life assessment
    label
    Epoetin alfa - 120000 Units
    type
    EXPERIMENTAL
  4. description
    500 mcg
    intervention Names
    1. Drug: darbepoetin alfa
    2. Drug: epoetin alfa
    3. Procedure: fatigue assessment and management
    4. Procedure: quality-of-life assessment
    label
    Darbepoetin alfa***
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Darbepoetin alfa***
    2. Epoetin alfa - 120000 Units
    3. Epoetin alfa - 40000 units
    4. Epoetin alfa - 80000 units
    name
    darbepoetin alfa
    type
    DRUG
  2. arm Group Labels
    1. Darbepoetin alfa***
    2. Epoetin alfa - 120000 Units
    3. Epoetin alfa - 40000 units
    4. Epoetin alfa - 80000 units
    name
    epoetin alfa
    type
    DRUG
  3. arm Group Labels
    1. Darbepoetin alfa***
    2. Epoetin alfa - 120000 Units
    3. Epoetin alfa - 40000 units
    4. Epoetin alfa - 80000 units
    name
    fatigue assessment and management
    type
    PROCEDURE
  4. arm Group Labels
    1. Darbepoetin alfa***
    2. Epoetin alfa - 120000 Units
    3. Epoetin alfa - 40000 units
    4. Epoetin alfa - 80000 units
    name
    quality-of-life assessment
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
239
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    A hematopoietic response was defined as Hb rise \>2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period
    measure
    The Percentage of Participants Who Exhibit a Hematopoietic Response
    time Frame
    20 weeks
secondary Outcomes
  1. description
    To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule
    measure
    Weekly Change in Hemoglobin Levels
    time Frame
    Baseline and Week 4, 7, 10, 13, 16
  2. description
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
    measure
    Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL
    time Frame
    16 weeks
  3. description
    To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule. The positive numbers represent hemoglobin increases and negative numbers represent hemoglobin decreases.
    measure
    Mean Hemoglobin Change From Week 1 to Week 16
    time Frame
    Week 1 and Week 16
  4. description
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
    measure
    The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions
    time Frame
    16 weeks
  5. description
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
    measure
    The Total RBC Transfusion Needed
    time Frame
    16 weeks
  6. description
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
    measure
    The Percentage of Participants With Dose Omitted Due to Hematologic Reason
    time Frame
    16 Weeks
  7. description
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Adverse events were measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
    measure
    The Percentage of Participants Reported Grade 3 or 4 Adverse Events
    time Frame
    16 weeks
  8. description
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. FACT-AN consist of Fatigue concerns subscale and non-fatigue concerns subscale. FACT Total Anemia score was calculated by adding the two subscales scores and transformed into 0-100 scale. FACT Total Anemia, Fatigue concerns scale and Non-Fatigue concerns scale are all ranges: 0 (Worst QOL) to 100 (Best QOL). Average scores across all time points for each subscale and total scale were calculated.
    measure
    Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations
    time Frame
    Weeks 4, 7, 10, 13 and 16
  9. description
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Linear Analogue Self Assessment (LASA) consists of 10 single-item numeric analogue scales on a scale of 0 to 10. Higher scores indicate better quality of life (QOL) on overall QOL, mental, physical, emotional spiritual QOL and Social activity; and constant pain, highest pain severity, level of fatigue and anxiety. Average scores across all time points for each item were calculated.
    measure
    Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
    time Frame
    Weeks 4, 7, 10, 13 and 16
  10. description
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Brief Fatigue Inventory (BFI) consist of 3 single-item numeric analogue scales on a scale of 0 to 10; and an interference scale formed by 6 single-item numeric scales on a scale of 0 to 10. Higher scores indicate fatigue as bad as you can imagine for fatigue now, usual fatigue and worse fatigue; and completely interferes for BFI interference. Average scores across all time points for fatigue now, usual fatigue, worst fatigue and BFI interference subscale were calculated.
    measure
    Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations
    time Frame
    Weeks 4, 7, 10, 13 and 16
  11. description
    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. SDS Scale range: 1 (No Symptom), 5 (Worst Symptom). Average scores across all time points for each item were calculated.
    measure
    Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
    time Frame
    Weeks 4, 7, 10, 13 and 16
Full study description
brief Summary
RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with cancer. PURPOSE: This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with anemia caused by chemotherapy.
detailed Description
OBJECTIVES: Primary * Compare the relative efficacy of four different erythropoietic agent dosing schedules comprising epoetin alfa or darbepoetin alfa, in terms of the proportion of patients with chemotherapy-associated anemia who achieve a weekly and overall hematopoietic response. Secondary * Compare the effect of these regimens on the mean hemoglobin increment measured weekly from baseline to 15 weeks in patients with a baseline hemoglobin of less than or equal to 10.5 g/dL. * Compare the time required to achieve hemoglobin levels within the goal range 11.0-12.0 g/dL in patients treated with these regimens. * Compare the effect of these regimens on the proportion of patients requiring red blood cell transfusions and on the number of transfusions required. * Compare the weekly change in hemoglobin in patients treated with these regimens. * Compare the need for dose reduction in patients treated with these regimens. * Compare the adverse event profiles of these regimens in these patients. * Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, unblinded, pilot study. Patients are stratified according to severity of anemia (mild \[hemoglobin ≥ 9.5 g/dL\] vs severe \[hemoglobin \< 9.5 g/dL\]), platinum-containing regimen (yes vs no), and tumor type (nonmyeloid hematologic malignancy vs solid tumor). Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive epoetin alfa subcutaneously (SC) on day 1. Treatment repeats weekly for up to 15 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm I). Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. * Arm III: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm II). Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. * Arm IV: Patients receive darbepoetin alfa SC on day 1. Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. Hemoglobin levels are monitored throughout the study on a weekly basis and before each drug dose is administered. Drug dosing is adjusted (e.g., held, reduced, resumed at a lower dose) as needed to maintain hemoglobin values within the desired ranges. Quality of life is assessed at baseline and at weeks 4, 7, 10, 13, and 16. After completion of study treatment, patients are followed at 30 days. PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study.
Source references
Source notices and limitations
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      nct-edge-f18f968d6e38eac89dff
      requested nct id
      NCT00416624
      primary nct id
      NCT00416624
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      payload sha256
      7a4b98e911420f245244b0a09a31397496a0c833fe2c64478e9321998b1766bc
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-f18f968d6e38eac89dff
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00416624
      occurrences
      1. context exact
        NCT00416624
        end
        11
        exact text
        NCT00416624
        start
        0
      offset unit
      unicode_code_points
      query cond
      Hairy Cell Leukemia
      query disease state id
      ds-hairy-cell-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-hairy-cell-leukemia-000.json
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      source json pointer
      /studies/6/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      b072843af957eb1f24a6b5a78d08a02d883d4eda940a5bcbb6062042b3ed31cf

    Preserved source evidence · Not medical advice