AnemiaPhase 3NCT00070382
Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
A Phase 3 study testing darbepoetin alfa and epoetin alfa in people with Anemia and Leukemia, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- darbepoetin alfa and epoetin alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Nov 2003
- Phase
- Phase 3
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a non-myeloid malignancy
- Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy
- Hemoglobin no greater than 11.0 g/dL
- 18 and over
- ECOG 0-2
- Bilirubin less than 2 times upper limit of normal (ULN)
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- Creatinine less than 2 times ULN
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- More than 30 days since prior darbepoetin alfa or epoetin alfa
- More than 30 days since prior participation in investigational device or drug trials
Who cannot join
- The following diagnoses are excluded:
- Acute myeloid leukemia
- Chronic myeloid leukemia
- Acute lymphoblastic leukemia
- Hairy cell leukemia
- Burkitt's lymphoma
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- Lymphoblastic lymphoma
- other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)
- angina
- congestive heart failure
- New York Heart Association class III or IV heart disease
- hypertension
- cardiac arrhythmia
- other unstable or uncontrolled disease or condition that would affect cardiac function
- pregnant or nursing
- known seizure disorder
- known sensitivity to study agents
- clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)
- confirmed neutralizing antibodies to epoetin alfa
- other disorder that would preclude study compliance or giving informed consent
- other concurrent epoetin alfas
- prior randomization to this study
- other concurrent investigational agents or procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095
About this study
Official title: A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy
RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12 weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).
- Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are followed at 1 and 3 weeks .
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.
- Conditions
- Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous/Nonmalignant Condition
- Being tested
- darbepoetin alfa, epoetin alfa
- Keywords
- anemia, unspecified adult solid tumor, protocol specific, Waldenstrom macroglobulinemia, monoclonal gammopathy of undetermined significance, extramedullary plasmacytoma, isolated plasmacytoma of bone, refractory multiple myeloma, primary systemic amyloidosis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, post-transplant lymphoproliferative disorder, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent adult T-cell leukemia/lymphoma, stage I adult T-cell leukemia/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
darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period
epoetin alfaDrug
epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa | Experimental | darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period. Receives: Drug: darbepoetin alfa |
| Epoetin alfa | Active comparator | epoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period. Receives: Drug: epoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startAug 2003
- Primary completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- John A. Glaspy, MD, MPH, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070382
- Sponsor's protocol ID
- CDR0000333213
- Other IDs
- UCLA-0306021, AMGEN-20030125
- Status last verified
- Aug 2012
- First submitted
- 3 Oct 2003
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
20030125 Study Group Trial; Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. J Clin Oncol. 2006 May 20;24(15):2290-7. doi: 10.1200/JCO.2005.03.8570.
PubMed 16710026