AnemiaPhase 3NCT00058331
Epoetin Alfa in Treating Anemia in Patients With Solid Tumors
A Phase 3 study testing epoetin alfa in people with Anemia and Leukemia, run by Alliance for Clinical Trials in Oncology at 18 sites in United States.
Trial summary
RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 365 participants
- Where
- 18 sitesUnited States
- Study dates
- Jun 2003to May 2006
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer)
- Anemia secondary to cancer or cancer treatment*
- Hemoglobin less than 12 g/dL (males)
- Hemoglobin less than 11 g/dL (females) NOTE: *Active anticancer therapy is not required for study enrollment
- Anemia must not be secondary to any of the following:
- B_12, folic acid, or iron deficiency
- Ferritin must be normal or elevated
- Gastrointestinal bleeding or hemolysis
- Primary or chemotherapy-induced myelodysplastic syndromes
- No untreated CNS metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Cardiovascular
- No history of uncontrolled cardiac arrhythmias
- No history of deep venous thrombosis within the past year (unless on anticoagulation)
- No uncontrolled hypertension (systolic blood pressure at least 180 mm Hg and diastolic blood pressure at least 100 mm Hg) within the past year (unless on anticoagulation)
Pulmonary
- No history of pulmonary embolism within the past year (unless on anticoagulation)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No known hypersensitivity to epoetin alfa, mammalian cell-derived products, or human albumin
- No new onset of seizures within the past 3 months
- No poorly controlled seizures
- Able and willing to complete quality of life forms
- Alert and mentally competent to give informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 6 months since prior epoetin alfa
- More than 6 months since any prior investigational forms of epoetin alfa (e.g., gene-activated epoetin alfa or novel erythropoiesis-stimulating protein)
- No concurrent peripheral blood stem cell transplantation
- No concurrent bone marrow transplantation
Surgery
- More than 14 days since prior major surgery
Other
- More than 2 weeks since prior red blood cell transfusions
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
CCOP - Duluth
Duluth, Minnesota, 55805
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
Altru Cancer Center
Grand Forks, North Dakota, 58201
Mayo Clinic
Jacksonville, Florida, 32224
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
CCOP - Wichita
Wichita, Kansas, 67214-3882
About this study
Official title: A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia.
PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.
Read the detailed description
OBJECTIVES:
- Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer.
- Compare the effects of these regimens on increasing hemoglobin levels in these patients.
- Compare the effects of these regimens on overall quality of life (QOL) and anemia-specific components of QOL in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent chemotherapy or radiotherapy (yes vs no), concurrent platinum-based (cisplatin or carboplatin) chemotherapy (yes vs no), degree of anemia (mild [hemoglobin at least 9.0 g/dL] vs severe [hemoglobin less than 9.0 g/dL]), age (60 and under vs over 60), and type of neoplasm (plasma cell disorder [including multiple myeloma] or lymphoproliferative disorder [including non-Hodgkin's lymphoma and chronic lymphocytic leukemia] vs all other neoplasms).
All patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients are then randomized to 1 of 2 treatment arms.
- Conditions
- Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition
- Being tested
- epoetin alfa
- Medical subject headings
- Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaBiological
| Study group | Role | What they receive |
|---|---|---|
| epoetin alfa - long term dosing | Experimental | Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Then patients receive EPO SC once weekly for 18 weeks. Quality of life is assessed at randomization at then monthly during study treatment.
Patients are followed every 6 months for 1 year. Receives: Biological: epoetin alfa |
| epoetin alfa - short term dosing | Experimental | Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients receive EPO SC on day 1 of weeks 4, 7, 10, 13, 16, and 19. Quality of life is assessed at randomization at then monthly during study treatment.
Patients are followed every 6 months for 1 year. Receives: Biological: epoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effects of these regimens on increasing hemoglobin levels
Measured: Up to 1 year post-treatment
Secondary outcomes (2)
Compare the effects of these regimens on overall quality of life (QOL)
Measured: Up to 1 year post-treatment
Compare the effects of anemia-specific components of QOL
Measured: Up to 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study startJun 2003
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David P. Steensma, MD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058331
- Sponsor's protocol ID
- NCCTG-N02C2
- Other IDs
- CDR0000288821
- Status last verified
- Jul 2016
- First submitted
- 7 Apr 2003
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Steensma DP, Molina R, Sloan JA, Nikcevich DA, Schaefer PL, Rowland KM Jr, Dentchev T, Novotny PJ, Tschetter LK, Alberts SR, Hogan TF, Law A, Loprinzi CL. Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer. J Clin Oncol. 2006 Mar 1;24(7):1079-89. doi: 10.1200/JCO.2005.02.7276.
PubMed 16505427Steensma DP, Molina R, Sloan JA, et al.: A phase III randomized trial of two different dosing schedules of erythropoietin (EPO) in patients with cancer-associated anemia: North Central Cancer Treatment Group (NCCTG) study N02C2. [Abstract] J Clin Oncol 23 (Suppl 16): A-8031, 736s, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
- ClinicalTrials.gov ID
- NCT00058331
- Acronym / sponsor ID
- NCCTG-N02C2
- Conditions
- Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2003
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 9 Apr 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: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia.
PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.
Detailed description
OBJECTIVES:
- Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer.
- Compare the effects of these regimens on increasing hemoglobin levels in these patients.
- Compare the effects of these regimens on overall quality of life (QOL) and anemia-specific components of QOL in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent chemotherapy or radiotherapy (yes vs no), concurrent platinum-based (cisplatin or carboplatin) chemotherapy (yes vs no), degree of anemia (mild [hemoglobin at least 9.0 g/dL] vs severe [hemoglobin less than 9.0 g/dL]), age (60 and under vs over 60), and type of neoplasm (plasma cell disorder [including multiple myeloma] or lymphoproliferative disorder [including non-Hodgkin's lymphoma and chronic lymphocytic leukemia] vs all other neoplasms).
All patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients are then randomized to 1 of 2 treatment arms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epoetin alfa - long term dosing | Experimental | Biological: epoetin alfaPatients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Then patients receive EPO SC once weekly for 18 weeks. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year. |
| epoetin alfa - short term dosing | Experimental | Biological: epoetin alfaPatients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients receive EPO SC on day 1 of weeks 4, 7, 10, 13, 16, and 19. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| epoetin alfa | Biological | epoetin alfa - long term dosing, epoetin alfa - short term dosing |
Primary outcome
Compare the effects of these regimens on increasing hemoglobin levels
Time frame: Up to 1 year post-treatment
2 secondary outcomes
Compare the effects of these regimens on overall quality of life (QOL)
Time frame: Up to 1 year post-treatment
Compare the effects of anemia-specific components of QOL
Time frame: Up to 1 year post-treatment
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 18 Jul 2016.
- Results publication: PubMed 16505427Steensma DP, Molina R, Sloan JA, Nikcevich DA, Schaefer PL, Rowland KM Jr, Dentchev T, Novotny PJ, Tschetter LK, Alberts SR, Hogan TF, Law A, Loprinzi CL. Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer. J Clin Oncol. 2006 Mar 1;24(7):1079-89. doi: 10.1200/JCO.2005.02.7276.
- Results publicationSteensma DP, Molina R, Sloan JA, et al.: A phase III randomized trial of two different dosing schedules of erythropoietin (EPO) in patients with cancer-associated anemia: North Central Cancer Treatment Group (NCCTG) study N02C2. [Abstract] J Clin Oncol 23 (Suppl 16): A-8031, 736s, 2005.
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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.
David P. Steensma, MD study chair
Dana-Farber Cancer Institute
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin alfa in people with Anemia and Leukemia, run by Alliance for Clinical Trials in Oncology at 18 sites 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 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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 the effects of these regimens on increasing hemoglobin levels (time frame: Up to 1 year post-treatment). 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 NCT00058331, which also lists 2 linked publications.
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 18 Jul 2016.