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
- Are there results?
- None posted in the registry
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.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00070382
- Acronym / sponsor ID
- CDR0000333213
- Conditions
- Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous/Nonmalignant Condition
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Aug 2003
- Primary completion
- Nov 2003 (actual)
- First posted
- 7 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin alfa | Experimental | Drug: darbepoetin alfadarbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period. |
| Epoetin alfa | Active comparator | Drug: epoetin alfaepoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (23 listed)
- The following diagnoses are excluded:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| darbepoetin alfadarbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period | Drug | Darbepoetin alfa |
| epoetin alfaepoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period | Drug | Epoetin alfa |
Primary outcome
Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Results publication: PubMed 1671002620030125 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A. Glaspy, MD, MPH principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00070382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.