Breast CancerPhase 1NCT00724386
Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer
A Phase 1 study testing Paclitaxel, Vinorelbine and Filgrastim in people with Breast Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The goal of this study is to determine the feasibility based on toxicity and response rate of giving paclitaxel weekly with concomitant every-other week radiotherapy to limit skin toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Paclitaxel, Vinorelbine and Filgrastim
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to Nov 2012
- Phase
- Phase 1
- 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
- Histologically or cytologically confirmed adenocarcinoma of the male or female breast (male or female) with gross, uncontrolled, unresectable breast and/or chest wall disease including:
- patients with locally advanced unresectable stage IIIa or IIIb;
- patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
- patients with metastatic disease AND uncontrolled locoregional disease are eligible.
- Prior chemotherapy allowed, except for nitrosoureas and mitomycin chemotherapy or high dose chemotherapy with marrow or stem cell rescue.
- Prior palliative radiation to sites of metastases allowed (i.e. bone, brain, lung)
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- 4 weeks since any prior treatments (excluding hormonal therapy). Concurrent hormonal therapy is not allowed.
- Aged 18 years or older
- CALGB performance status of 0 - 2
- Life expectance of at least 12 weeks
- Initial Laboratory Data:
- ANC Count > 1500/mm3
- Platelet Count > 100,000/mm3
- Creatine ≤ 2.0 mg/dl
- Bilirubin ≤ 1.5 mg/dl
- ALT (SGPT) ≤ 3 times the upper limit of normal
- Signed informed consent
Who cannot join
- Prior breast or chest wall radiation is not allowed unless the proposed site radiation port does not overlap with prior ports
- Subjects must not be pregnant (females able to have children must have negative pregnancy test and agree to use adequate contraception)
- Patients with a documented hypersensitivity to E.coli derived proteins are excluded.
- No other serious medical condition such as uncontrolled infection that in the opinion of the investigators places patient at undue risk for study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine With Filgrastim Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer
The goal of this study is to determine the feasibility based on toxicity and response rate of giving paclitaxel weekly with concomitant every-other week radiotherapy to limit skin toxicity. This study will also seek to determine the maximally tolerated dose of Navelbine added to this combination when followed by Filgrastim and the dose-limiting toxicities of this regimen.
- Conditions
- Breast Cancer
- Being tested
- Paclitaxel, Vinorelbine, Filgrastim, Radiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
1-hour IV infusion once weekly for 12 to 14 weeks
VinorelbineDrug
Also called Navelbine
escalating doses administered intravenously over 6-10 minutes for 12-14 weeks
FilgrastimDrug
daily injections for 6 days beginning on day 2 of second week on study and then every other week (weeks 2, 4, 6, 8, 12).
For the final dose cohort, administration on chemotherapy only weeks, only if dose reduction or dose delay required by subject
RadiationRadiation
Radiotherapy for 5 consecutive days every other week (weeks 1, 3, 5, 7, 9, 11, 13)starting on same day as first dose of protocol chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of administering study therapy to limit skin toxicity
Measured: 4 weeks
dose-limiting toxicity
Measured: 4 weeks
Secondary outcomes (4)
response
Measured: 14 weeks
time to progression
overall survival
Bcl-2 detection by immunohistochemistry
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJun 1999
- Primary completionOct 2005
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724386
- Sponsor's protocol ID
- UCIRB 9849
- Status last verified
- Mar 2014
- First submitted
- 25 Jul 2008
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine With Filgrastim Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00724386
- Acronym / sponsor ID
- UCIRB 9849
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Jun 1999
- Primary completion
- Oct 2005 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Jul 2008 (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 goal of this study is to determine the feasibility based on toxicity and response rate of giving paclitaxel weekly with concomitant every-other week radiotherapy to limit skin toxicity. This study will also seek to determine the maximally tolerated dose of Navelbine added to this combination when followed by Filgrastim and the dose-limiting toxicities of this regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed adenocarcinoma of the male or female breast (male or female) with gross, uncontrolled, unresectable breast and/or chest wall disease including:
- Prior chemotherapy allowed, except for nitrosoureas and mitomycin chemotherapy or high dose chemotherapy with marrow or stem cell rescue.
- Prior palliative radiation to sites of metastases allowed (i.e. bone, brain, lung)
- 4 weeks since any prior treatments (excluding hormonal therapy). Concurrent hormonal therapy is not allowed.
- Aged 18 years or older
Key exclusion criteria (4 listed)
- Prior breast or chest wall radiation is not allowed unless the proposed site radiation port does not overlap with prior ports
- Subjects must not be pregnant (females able to have children must have negative pregnancy test and agree to use adequate contraception)
- Patients with a documented hypersensitivity to E.coli derived proteins are excluded.
- No other serious medical condition such as uncontrolled infection that in the opinion of the investigators places patient at undue risk for study treatment
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 |
|---|---|---|
| PaclitaxelAlso: Taxol1-hour IV infusion once weekly for 12 to 14 weeks | Drug | – |
| VinorelbineAlso: Navelbineescalating doses administered intravenously over 6-10 minutes for 12-14 weeks | Drug | – |
| Filgrastimdaily injections for 6 days beginning on day 2 of second week on study and then every other week (weeks 2, 4, 6, 8, 12). For the final dose cohort, administration on chemotherapy only weeks, only if dose reduction or dose delay required by subject | Drug | – |
| RadiationRadiotherapy for 5 consecutive days every other week (weeks 1, 3, 5, 7, 9, 11, 13)starting on same day as first dose of protocol chemotherapy | Radiation | – |
Primary outcome
feasibility of administering study therapy to limit skin toxicity
Time frame: 4 weeks
dose-limiting toxicity
Time frame: 4 weeks
4 secondary outcomes
response
Time frame: 14 weeks
time to progression
overall survival
Bcl-2 detection by immunohistochemistry
Time frame: 14 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 7 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paclitaxel, Vinorelbine and Filgrastim in people with Breast Cancer, run by University of Chicago 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 17 inclusion and 4 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 7 Mar 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
feasibility of administering study therapy to limit skin toxicity (time frame: 4 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?
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 7 Mar 2014; AzTrials last refreshed its copy on 7 Nov 2026.