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AnemiaPhase 2NCT00416624

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

A Phase 2 study testing darbepoetin alfa, epoetin alfa and fatigue assessment and management in people with Anemia and Leukemia, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Anemia, Leukemia, Lymphoma
What is being tested?
darbepoetin alfa, epoetin alfa and fatigue assessment and management
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
239 participants
Where
1 siteUnited States
Study dates
May 2007to Jun 2009
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: RC05CB A Pilot, Randomized Comparison of Standard Weekly Epoetin Alfa to Every-3-Week-Epoetin Alfa and Every 3-Week Darbepoetin Alfa

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.

Read the 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.

Being tested
darbepoetin alfa, epoetin alfa, fatigue assessment and management, quality-of-life assessment
Keywords
unspecified adult solid tumor, protocol specific, extramedullary plasmacytoma, isolated plasmacytoma of bone, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, Waldenstrom macroglobulinemia, post-transplant lymphoproliferative disorder, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, recurrent adult T-cell leukemia/lymphoma, AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma
Medical subject headings
Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Precancerous Conditions, Waldenstrom Macroglobulinemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • darbepoetin alfaDrug

  • epoetin alfaDrug

  • fatigue assessment and managementProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

Study groups in NCT00416624
Study groupRoleWhat they receive
Epoetin alfa - 40000 unitsExperimental40,000 Units
Receives: Drug: darbepoetin alfa; Drug: epoetin alfa; Procedure: fatigue assessment and management; Procedure: quality-of-life assessment
Epoetin alfa - 80000 unitsExperimental80,000 Units
Receives: Drug: darbepoetin alfa; Drug: epoetin alfa; Procedure: fatigue assessment and management; Procedure: quality-of-life assessment
Epoetin alfa - 120000 UnitsExperimental120,000 Units
Receives: Drug: darbepoetin alfa; Drug: epoetin alfa; Procedure: fatigue assessment and management; Procedure: quality-of-life assessment
Darbepoetin alfa***Experimental500 mcg
Receives: Drug: darbepoetin alfa; Drug: epoetin alfa; Procedure: fatigue assessment and management; Procedure: quality-of-life assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Percentage of Participants Who Exhibit a Hematopoietic Response

    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

    Measured: 20 weeks

Secondary outcomes (11)
  1. Weekly Change in Hemoglobin Levels

    To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule

    Measured: Baseline and Week 4, 7, 10, 13, 16

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

    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule

    Measured: 16 weeks

  3. Mean Hemoglobin Change From Week 1 to Week 16

    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.

    Measured: Week 1 and Week 16

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

    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule

    Measured: 16 weeks

  5. The Total RBC Transfusion Needed

    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule

    Measured: 16 weeks

  6. The Percentage of Participants With Dose Omitted Due to Hematologic Reason

    To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule

    Measured: 16 Weeks

  7. The Percentage of Participants Reported Grade 3 or 4 Adverse Events

    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.

    Measured: 16 weeks

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

    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.

    Measured: Weeks 4, 7, 10, 13 and 16

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

    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.

    Measured: Weeks 4, 7, 10, 13 and 16

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

    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.

    Measured: Weeks 4, 7, 10, 13 and 16

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

    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.

    Measured: Weeks 4, 7, 10, 13 and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2006 (estimated)
  2. Study startMay 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00416624
Sponsor's protocol ID
CDR0000522677
Other IDs
P30CA015083, RC05CB, 06-002991, EPOANE3015
Status last verified
Sep 2015
First submitted
27 Dec 2006
Last updated
10 Feb 2017
Data monitoring committee
Yes

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