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.
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
- 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.
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.
- Conditions
- Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition
- 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 group | Role | What they receive |
|---|---|---|
| Epoetin alfa - 40000 units | Experimental | 40,000 Units Receives: Drug: darbepoetin alfa; Drug: epoetin alfa; Procedure: fatigue assessment and management; Procedure: quality-of-life assessment |
| Epoetin alfa - 80000 units | Experimental | 80,000 Units Receives: Drug: darbepoetin alfa; Drug: epoetin alfa; Procedure: fatigue assessment and management; Procedure: quality-of-life assessment |
| Epoetin alfa - 120000 Units | Experimental | 120,000 Units Receives: Drug: darbepoetin alfa; Drug: epoetin alfa; Procedure: fatigue assessment and management; Procedure: quality-of-life assessment |
| Darbepoetin alfa*** | Experimental | 500 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.
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)
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
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
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
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
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
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
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
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
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
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
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.
- First posted28 Dec 2006 (estimated)
- Study startMay 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles L. Loprinzi, M.D., Study chair, Mayo Clinic
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes