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AnemiaPhase 2NCT00255749

Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer

A Phase 2 study testing epoetin alfa in people with Anemia and Leukemia, run by Jonsson Comprehensive Cancer Center 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 may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, Leukemia, Lymphoma
What is being tested?
epoetin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteUnited States
Study dates
Aug 2005to Apr 2007
Phase
Phase 2
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed nonmyeloid cancer
  • No history of myelodysplasia
  • Baseline hemoglobin 11-12 g/dL
  • No anemia due to factors other than cancer or chemotherapy (e.g., iron, cyanocobalamin [vitamin B_12], or folate deficiencies, hemolysis, or gastrointestinal bleeding)
  • Receiving chemotherapy that meets the following criteria:
  • Administered weekly OR every 3 weeks
  • Must begin chemotherapy on or before the first day of study treatment
  • No known, untreated CNS metastases

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3 (transfusion independent)
  • Iron transferrin saturation > 20%
  • No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)

Hepatic

  • Bilirubin < 2.0 mg/dL
  • SGPT ≤ 3 times upper limit of normal

Renal

  • Creatinine ≤ 1.5 mg/dL
  • No significant, uncontrolled genitourinary disease or dysfunction

Cardiovascular

  • No uncontrolled cardiac arrhythmia in the past 6 months
  • No uncontrolled hypertension
  • No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic events
  • Superficial thromboses allowed
  • No other significant, uncontrolled cardiovascular disease or dysfunction

Pulmonary

  • No significant, uncontrolled pulmonary disease or dysfunction
  • No pulmonary emboli

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No infection requiring hospitalization or antibiotics in the past 14 days
  • No known hypersensitivity to mammalian cell-derived products or to human albumin
  • No new onset (in the past 3 months) poorly controlled seizures
  • No other active malignancy except basal cell carcinoma or carcinoma in situ
  • Not an employee of the investigator or study center or family members of the employee or the investigator
  • No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or dysfunction

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Chemotherapy
  • More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin alfa, or gene-activated erythropoietin)
  • More than 4 weeks since prior packed red blood cell transfusion
  • No concurrent stem cell harvest of bone marrow
  • No concurrent interleukin-11
  • No other concurrent erythropoietic agent

Chemotherapy

  • See Disease Characteristics
  • No concurrent high-dose chemotherapy with stem cell transplantation

Radiotherapy

  • No concurrent nonpalliative radiotherapy

Surgery

  • More than 2 weeks since prior major surgery

Other

  • At least 1 month since prior investigational agents or devices
  • No concurrent high-dose IV iron supplementation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy

RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy.

PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in patients with anemia undergoing chemotherapy for nonmyeloid cancer.
  • Determine the safety of this drug in these patients.

Secondary

  • Determine the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (early intervention): Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
  • Arm II (standard intervention): Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.

Quality of life is assessed prior to start of study treatment, at week 7 during study treatment, and after completion of study treatment.

After completion of study treatment, patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

Being tested
epoetin alfa
Keywords
adult acute lymphoblastic leukemia in remission, progressive hairy cell leukemia, initial treatment, stage 0 chronic lymphocytic leukemia, anemia, extramedullary plasmacytoma, isolated plasmacytoma of bone, refractory multiple myeloma, monoclonal gammopathy of undetermined significance, primary systemic amyloidosis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma
Medical subject headings
Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Precancerous Conditions, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • epoetin alfaBiological

Study groups in NCT00255749
Study groupRoleWhat they receive
early intervention epoietin alfaExperimentalPatients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
Receives: Biological: epoetin alfa
standard intervention epoietin alfaOtherPatients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.
Receives: Biological: epoetin alfa

What is being measured

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

  1. Efficacy

    Measured: 7 weeks

  2. Safety

    Measured: 7 weeks

Secondary outcomes (1)

  1. Quality of life

    Measured: 7 weeks

Timeline

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

  1. First posted21 Nov 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionApr 2007

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
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00255749
Sponsor's protocol ID
CDR0000449950
Other IDs
UCLA-0504038, ORTHO-PR04-27-018
Status last verified
Oct 2012
First submitted
18 Nov 2005
Last updated
4 Oct 2012
Results posted
No

Publications

  • Glaspy JA, Charu V, Luo D, Moyo V, Kamin M, Wilhelm FE. Initiation of epoetin-alpha therapy at a starting dose of 120,000 units once every 3 weeks in patients with cancer receiving chemotherapy: an open-label, multicenter study with randomized and nonrandomized treatment arms. Cancer. 2009 Mar 1;115(5):1121-31. doi: 10.1002/cncr.24127.

    PubMed 19170225

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 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?

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 4 Oct 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Efficacy (time frame: 7 weeks). The study lists 2 primary outcomes in all. 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 NCT00255749, 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 4 Oct 2012.

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