NeutropeniaPhase 4NCT00277160
A Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis After Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer
A Phase 4 study testing Neulasta (pegfilgrastim) in people with Neutropenia and Breast Cancer, run by Amgen.
Trial summary
The purpose of this study is to assess pegfilgrastim starting with the first cycle versus secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays, dose reductions, and hospitalizations) in older patients receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neutropenia, Breast Cancer, Lung Cancer
- What is being tested?
- Neulasta (pegfilgrastim)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Jan 2005
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >/= 65 years old
- documented diagnosis of lung, breast, or ovarian cancer, or NHL
- scheduled to receive one of 15 standard chemotherapy regimens
- chemotherapy naive OR have received adjuvant therapy AND/OR have no more than one regimen of chemotherapy for metastatic disease
- life expectancy of at least 3 months
- ECOG performance status </=2
- adequate renal and hematologic function
- informed consent for participation in the study prior to any study specific procedures
Who cannot join
- known hypersensitivity to any of the products to be administered during dosing
- primary prophylactic antibiotics in all cycles
- prior radiation therapy within 2 weeks of randomization into this study or plan for radiation therapy during study participation, except for spot radiation for bony metastases
- prior bone marrow or stem cell transplant or plan to receive any transplant therapy during study participation
- clinically symptomatic brain metastases
- Folstein mini-mental state exam score <18
Show all 11Show fewer
- Any premalignant myeloid condition or any malignancy with myeloid characteristics
- History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, in situ cervical carcinoma or surgically cured malignancies
- unstable/uncontrolled cardiac conditions or hypertension
- active infection
- subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving other investigational agents
About this study
Official title: A Randomized, Open Label, Multicenter Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis as an Adjunct to Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer
The purpose of this study is to assess pegfilgrastim starting with the first cycle versus secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays, dose reductions, and hospitalizations) in older patients receiving chemotherapy.
- Conditions
- Neutropenia, Breast Cancer, Lung Cancer, Non-Hodgkin's Lymphoma, Ovarian Cancer
- Being tested
- Neulasta (pegfilgrastim)
- Medical subject headings
- Neutropenia, Breast Neoplasms, Lung Neoplasms, Lymphoma, Non-Hodgkin, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neulasta (pegfilgrastim)Drug
Commercial pegfilgrastim 6mg single subcutaneous fixed-dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 (Primary Prophylaxis) | Experimental | Neulasta 6mg single administration per cycle of chemotherapy starting with cycle 1 Receives: Drug: Neulasta (pegfilgrastim) |
| Treatment Group 2 (Secondary Prophylaxis) | Active comparator | Per Investigator's discretion Receives: Drug: Neulasta (pegfilgrastim) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day
Measured: End of the last cycle of chemotherapy or the date of early termination from the study
Secondary outcomes (3)
Incidence of grade 3 and 4 neutropenia
Measured: End of the last cycle of chemotherapy or the date of early termination from the study
Dose delays or dose reductions
Measured: End of the last cycle of chemotherapy or the date of early termination from the study
Incidence of febrile neutropenia with a more strict definition (ANC < 0.5 x 10^9/L and temperature ≥ 38o C), on the same day
Measured: End of the last cycle of chemotherapy or the date of early termination from the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startJun 2002
- Primary completionNov 2004
- Study completionJan 2005
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 NeutropeniaStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 852 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277160
- Sponsor's protocol ID
- 20020122
- Status last verified
- Oct 2010
- First submitted
- 12 Jan 2006
- Last updated
- 8 Oct 2010
- Results posted
- No
Publications
Balducci L, Al-Halawani H, Charu V, Tam J, Shahin S, Dreiling L, Ershler WB. Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim. Oncologist. 2007 Dec;12(12):1416-24. doi: 10.1634/theoncologist.12-12-1416.
PubMed 18165618Flores IQ, Ershler W. Managing neutropenia in older patients with cancer receiving chemotherapy in a community setting. Clin J Oncol Nurs. 2010 Feb;14(1):81-6. doi: 10.1188/10.CJON.81-86.
PubMed 20118030
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multicenter Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis as an Adjunct to Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer
- ClinicalTrials.gov ID
- NCT00277160
- Acronym / sponsor ID
- 20020122
- Conditions
- Neutropenia, Breast Cancer, Lung Cancer, Non-Hodgkin's Lymphoma, Ovarian Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 852 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Nov 2004 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 16 Jan 2006 (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.
The purpose of this study is to assess pegfilgrastim starting with the first cycle versus secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays, dose reductions, and hospitalizations) in older patients receiving chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 (Primary Prophylaxis) | Experimental | Drug: Neulasta (pegfilgrastim)Neulasta 6mg single administration per cycle of chemotherapy starting with cycle 1 |
| Treatment Group 2 (Secondary Prophylaxis) | Active comparator | Drug: Neulasta (pegfilgrastim)Per Investigator's discretion |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- >/= 65 years old
- documented diagnosis of lung, breast, or ovarian cancer, or NHL
- scheduled to receive one of 15 standard chemotherapy regimens
- chemotherapy naive OR have received adjuvant therapy AND/OR have no more than one regimen of chemotherapy for metastatic disease
- life expectancy of at least 3 months
Key exclusion criteria (11 listed)
- known hypersensitivity to any of the products to be administered during dosing
- primary prophylactic antibiotics in all cycles
- prior radiation therapy within 2 weeks of randomization into this study or plan for radiation therapy during study participation, except for spot radiation for bony metastases
- prior bone marrow or stem cell transplant or plan to receive any transplant therapy during study participation
- clinically symptomatic brain metastases
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 |
|---|---|---|
| Neulasta (pegfilgrastim)Commercial pegfilgrastim 6mg single subcutaneous fixed-dose | Drug | Treatment Group 1 (Primary Prophylaxis), Treatment Group 2 (Secondary Prophylaxis) |
Primary outcome
Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day
Time frame: End of the last cycle of chemotherapy or the date of early termination from the study
3 secondary outcomes
Incidence of grade 3 and 4 neutropenia
Time frame: End of the last cycle of chemotherapy or the date of early termination from the study
Dose delays or dose reductions
Time frame: End of the last cycle of chemotherapy or the date of early termination from the study
Incidence of febrile neutropenia with a more strict definition (ANC < 0.5 x 10^9/L and temperature ≥ 38o C), on the same day
Time frame: End of the last cycle of chemotherapy or the date of early termination from the study
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 8 Oct 2010.
- Results publication: PubMed 18165618Balducci L, Al-Halawani H, Charu V, Tam J, Shahin S, Dreiling L, Ershler WB. Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim. Oncologist. 2007 Dec;12(12):1416-24. doi: 10.1634/theoncologist.12-12-1416.
- Results publication: PubMed 20118030Flores IQ, Ershler W. Managing neutropenia in older patients with cancer receiving chemotherapy in a community setting. Clin J Oncol Nurs. 2010 Feb;14(1):81-6. doi: 10.1188/10.CJON.81-86.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neulasta (pegfilgrastim) in people with Neutropenia and Breast Cancer, run by Amgen.
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 8 inclusion and 11 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 8 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day (time frame: End of the last cycle of chemotherapy or the date of early termination from the study). 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 NCT00277160, 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 8 Oct 2010.