Breast CancerPhase 2NCT00117442
A Study of Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood
A Phase 2 study testing carboplatin, paclitaxel and pegfilgrastim in people with Breast Cancer and Lung Cancer, run by Amgen.
Trial summary
The purpose of this study is to provide dose-finding information regarding the efficacy and kinetics of peripheral blood progenitor cell (PBPC) mobilisation by pegfilgrastim and to determine if carboplatin/paclitaxel can be delivered at a reduced cycle interval when supported by pegfilgrastim-mobilised PBPCs in whole… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer, Lung Cancer, Ovarian Cancer
- What is being tested?
- carboplatin, paclitaxel and pegfilgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Dec 2004
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: - Pathologically confirmed diagnosis of malignancy (solid tumour) suitable for treatment with intensified carboplatin and paclitaxel - Previously untreated with chemotherapy or radiotherapy - ECOG performance status 0 to 2 inclusive - Life expectancy greater than or equal to 12 weeks - ANC greater than or equal to 2.0 x 10^9/L, platelets greater than 100 x 10^9/L - Glomerular filtration rate greater than 60 mL/min Exclusion Criteria: - Active infection requiring treatment with systemic (IV or oral) anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of randomisation - Known to be HIV positive - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) - Prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, and/or carcinoma of the cervix in-situ - History of impaired cardiac status [e.g., severe heart disease (NYHA greater than 2), cardiomyopathy, or congestive heart failure] - Bone marrow involvement of disease - Major surgery within 2 weeks before randomisation - Known sensitivity to E. coli derived drug products (e.g., filgrastim) - Previous exposure to pegfilgrastim
About this study
Official title: An Open-Label, Randomised Study of Multi-Cycle, Dose Intensive Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood
The purpose of this study is to provide dose-finding information regarding the efficacy and kinetics of peripheral blood progenitor cell (PBPC) mobilisation by pegfilgrastim and to determine if carboplatin/paclitaxel can be delivered at a reduced cycle interval when supported by pegfilgrastim-mobilised PBPCs in whole blood.
- Conditions
- Breast Cancer, Lung Cancer, Ovarian Cancer
- Being tested
- carboplatin, paclitaxel, pegfilgrastim
- Keywords
- solid tumour, unknown primary tumour, carboplatin, paclitaxel
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Chemotherapy
paclitaxelDrug
chemotherapy
pegfilgrastimDrug
Growth factor for mobilization
| Study group | Role | What they receive |
|---|---|---|
| Pegfilgrastim 18 mg | Experimental | Pegfilgrastim 18 mg given once for mobilization Receives: Drug: carboplatin; Drug: paclitaxel; Drug: pegfilgrastim |
| Filgrastim | Active comparator | Filgrastim given daily for mobilization Receives: Drug: carboplatin; Drug: paclitaxel |
| Pegfilgrastim 12 mg | Experimental | Pegfilgrastim 12 mg given once for mobilization Receives: Drug: carboplatin; Drug: paclitaxel; Drug: pegfilgrastim |
| Pegfilgrastim 6 mg | Experimental | Pegfilgrastim 6 mg given once for mobilization Receives: Drug: carboplatin; Drug: paclitaxel; Drug: pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time.
Measured: Cycle 0, and through 4 cycles
Secondary outcomes (1)
PBPC kinetics and response to chemotherapy treatment
Measured: Cycles 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2005 (estimated)
- Study startAug 2002
- Primary completionAug 2004
- Study completionDec 2004
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 Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117442
- Sponsor's protocol ID
- 20010191
- Status last verified
- May 2013
- First submitted
- 30 Jun 2005
- Last updated
- 13 May 2013
- Results posted
- No
Publications
Willis F, Theti D, Dean S, Bacon P, Baker N, Pettengell R. Pegfilgrastim successfully mobilizes megakaryocyte progenitors into the peripheral blood in subjects with solid tumours. Bone Marrow Transplant. 2008 Aug;42(3):167-73. doi: 10.1038/bmt.2008.147. Epub 2008 May 26.
PubMed 18500375Willis F, Woll P, Theti D, Jamali H, Bacon P, Baker N, Pettengell R. Pegfilgrastim for peripheral CD34+ mobilization in patients with solid tumours. Bone Marrow Transplant. 2009 Jun;43(12):927-34. doi: 10.1038/bmt.2008.411. Epub 2009 Jan 26.
PubMed 19169289
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomised Study of Multi-Cycle, Dose Intensive Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood
- ClinicalTrials.gov ID
- NCT00117442
- Acronym / sponsor ID
- 20010191
- Conditions
- Breast Cancer, Lung Cancer, Ovarian Cancer
- Keywords
- solid tumour, unknown primary tumour, carboplatin, paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Aug 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 7 Jul 2005 (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 provide dose-finding information regarding the efficacy and kinetics of peripheral blood progenitor cell (PBPC) mobilisation by pegfilgrastim and to determine if carboplatin/paclitaxel can be delivered at a reduced cycle interval when supported by pegfilgrastim-mobilised PBPCs in whole blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pegfilgrastim 18 mg | Experimental | Drug: carboplatin, Drug: paclitaxel, Drug: pegfilgrastimPegfilgrastim 18 mg given once for mobilization |
| Filgrastim | Active comparator | Drug: carboplatin, Drug: paclitaxelFilgrastim given daily for mobilization |
| Pegfilgrastim 12 mg | Experimental | Drug: carboplatin, Drug: paclitaxel, Drug: pegfilgrastimPegfilgrastim 12 mg given once for mobilization |
| Pegfilgrastim 6 mg | Experimental | Drug: carboplatin, Drug: paclitaxel, Drug: pegfilgrastimPegfilgrastim 6 mg given once for mobilization |
Who may qualify
- Ages
- 18 to 65 years
- 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 |
|---|---|---|
| carboplatinChemotherapy | Drug | Filgrastim, Pegfilgrastim 12 mg, Pegfilgrastim 18 mg, Pegfilgrastim 6 mg |
| paclitaxelchemotherapy | Drug | Filgrastim, Pegfilgrastim 12 mg, Pegfilgrastim 18 mg, Pegfilgrastim 6 mg |
| pegfilgrastimGrowth factor for mobilization | Drug | Pegfilgrastim 12 mg, Pegfilgrastim 18 mg, Pegfilgrastim 6 mg |
Primary outcome
PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time.
Time frame: Cycle 0, and through 4 cycles
1 secondary outcome
PBPC kinetics and response to chemotherapy treatment
Time frame: Cycles 1-4
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 13 May 2013.
- Results publication: PubMed 18500375Willis F, Theti D, Dean S, Bacon P, Baker N, Pettengell R. Pegfilgrastim successfully mobilizes megakaryocyte progenitors into the peripheral blood in subjects with solid tumours. Bone Marrow Transplant. 2008 Aug;42(3):167-73. doi: 10.1038/bmt.2008.147. Epub 2008 May 26.
- Results publication: PubMed 19169289Willis F, Woll P, Theti D, Jamali H, Bacon P, Baker N, Pettengell R. Pegfilgrastim for peripheral CD34+ mobilization in patients with solid tumours. Bone Marrow Transplant. 2009 Jun;43(12):927-34. doi: 10.1038/bmt.2008.411. Epub 2009 Jan 26.
- FDA-approved Drug LabelingLink provided by the sponsor.
- 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 2 study testing carboplatin, paclitaxel and pegfilgrastim in people with Breast Cancer and Lung 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?
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 13 May 2013. 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 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?
PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time. (time frame: Cycle 0, and through 4 cycles). 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 NCT00117442, 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 13 May 2013.