Breast CancerPhase 1NCT02058667
Reirradiation With Concurrent Paclitaxel for Breast Cancer
A Phase 1 study testing Paclitaxel+Initial Radiation+Boost in people with Breast Cancer, run by University of Kentucky at 1 site in United States.
Trial summary
The purpose of this trial in addition to a dose finding study for concurrent Paclitaxel, will be to establish a treatment algorithm for chest wall reirradiation. A nominal margin of at least 5cm will be used on the protocol and extending it to 7cm. 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+Initial Radiation+Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2015
- 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
- Pathologically proven diagnosis of breast cancer with clinical evidence of recurrent disease on the chest wall following treatment that included radiotherapy, and for which there is no current standard of care or curative resection able to be performed
- Patients are permitted to have received prior therapy, but must have received a minimum of 30 Gy to the chest wall with a minimal interval since completion of radiation therapy equal to or greater than 6 months.
- Patients are permitted to have been treated with previous systemic chemotherapy. A minimal time interval since last dose of cytotoxic chemotherapy must be equal to or greater than 21 days, and all acute toxicities should be resolved to less than grade 2, and hematologic counts should meet study criteria. With regards to toxicity, patients who have left sided chest wall recurrences should not have previously exceeded more than 450 mg/m2 doxorubicin due to expected cumulative cardiotoxicity. Prior taxane therapy is allowed, however, there should be no reported anaphylactic reactions of grade 3 or higher.
- Age ≥18 years
- ECOG performance status ≤2
- Life expectancy of greater than 3 months
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- Normal organ and marrow function as defined below:
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin < 1.5 x institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine
- levels above institutional normal
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had radiotherapy within 6 months prior to entering the study or those who have not recovered to < grade 2 adverse events due to radiation
- Patients who have experienced a previous grade 3 or 4 anaphylactic reaction to Paclitaxel.
- Patients with grade > 2 neuropathy attributable to previous administration of Taxane chemotherapy.
- Patients who have received prior chemotherapy are allowed, provided they have been off systemic therapy for 21 days and all acute toxicities have resolved to less than grade 2. Patients who have received Paclitaxel within 3 months of study entry and have developed documented progressive disease despite therapy.
- Patients who are receiving any other investigational agents
- Patients with known brain metastases should have their brain metastases treated prior to enrollment on this protocol. Subjects may enroll on this trial after completion of whole brain radiation therapy and/or Stereotactic Radiosurgery, provided they are clinically without evidence of progressive brain metastases.
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- Patient who are actively receiving other cytotoxic or antibiologic chemotherapies. For patients with Her-2/neu positive disease, Trastuzumab (Herceptin) is NOT ALLOWED on this study, and should be withheld during the 8 weeks of therapy, and can be resumed no sooner than 14 days following completion of protocol therapy
- Women with a confirmed intrauterine pregnancy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because Paclitaxel is an antimicrotubule agent with known potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Paclitaxel, breastfeeding should be discontinued if the mother is treated with Paclitaxel
- HIV-positive patients on combination antiretroviral therapy are ineligible.
- Patients with poor cardiac function defined as an ejection fraction (EF) < 40% are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Twice Weekly Paclitaxel and Radical Re-irradiation Using Helical Tomotherapy for Aggressive Chest Wall Recurrences of Breast Cancer
The purpose of this trial in addition to a dose finding study for concurrent Paclitaxel, will be to establish a treatment algorithm for chest wall reirradiation. A nominal margin of at least 5cm will be used on the protocol and extending it to 7cm. Considering the standard treatment of breast cancer incorporates a cumulative dose of 60Gy, delivering an additional 50.4 Gy followed by a boost should target a total dose of 120 Gy.
- Conditions
- Breast Cancer
- Being tested
- Paclitaxel+Initial Radiation+Boost
- Keywords
- Breast Cancer, Paclitaxel, Helical Tomotherapy, Chest wall
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel+Initial Radiation+BoostRadiation
Paclitaxel twice weekly + Initial Fields Radiation + Boost Radiation (10Gy)
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel+Initial Radiation+Boost | Experimental | Paclitaxel twice weekly + Initial Fields Radiation + Boost Radiation (10Gy) Receives: Radiation: Paclitaxel+Initial Radiation+Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD identification
To identify the maximum tolerated dose of twice weekly Paclitaxel given concurrently with chest wall re-irradiation using helical tomotherapy for aggressive breast cancer recurrences
Measured: From first dose at week 1 until unacceptable toxicity occurs, up to 7 weeks
Secondary outcomes (4)
Time to progression
Measured: Up to 6 months
Local Control Rate of Dermal Disease at 6 months
Measured: 6 months
Rate of study-defined grade 1-2 toxicities, and all grade 3 or higher toxicities
Measured: Up to 6 months
Her-2/neu transformation
Her-2/neu transformation from initial therapy to the time of development of dermal metastasis or recurrence
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
Why it stopped: Slow accrual
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Michael Feddock, University of Kentucky
- Investigators
- Jonathan M Feddock, MD, Principal investigator, UK Markey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058667
- Sponsor's protocol ID
- 13-BRE-47-MCC
- Status last verified
- Nov 2016
- First submitted
- 31 Jan 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Twice Weekly Paclitaxel and Radical Re-irradiation Using Helical Tomotherapy for Aggressive Chest Wall Recurrences of Breast Cancer
- ClinicalTrials.gov ID
- NCT02058667
- Acronym / sponsor ID
- 13-BRE-47-MCC
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Paclitaxel, Helical Tomotherapy, Chest wall
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- First posted
- 10 Feb 2014 (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 trial in addition to a dose finding study for concurrent Paclitaxel, will be to establish a treatment algorithm for chest wall reirradiation. A nominal margin of at least 5cm will be used on the protocol and extending it to 7cm. Considering the standard treatment of breast cancer incorporates a cumulative dose of 60Gy, delivering an additional 50.4 Gy followed by a boost should target a total dose of 120 Gy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel+Initial Radiation+Boost | Experimental | Radiation: Paclitaxel+Initial Radiation+BoostPaclitaxel twice weekly + Initial Fields Radiation + Boost Radiation (10Gy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Pathologically proven diagnosis of breast cancer with clinical evidence of recurrent disease on the chest wall following treatment that included radiotherapy, and for which there is no current standard of care or curative resection able to be performed
- Patients are permitted to have received prior therapy, but must have received a minimum of 30 Gy to the chest wall with a minimal interval since completion of radiation therapy equal to or greater than 6 months.
- Patients are permitted to have been treated with previous systemic chemotherapy. A minimal time interval since last dose of cytotoxic chemotherapy must be equal to or greater than 21 days, and all acute toxicities should be resolved to less than grade 2, and hematologic counts should meet study criteria. With regards to toxicity, patients who have left sided chest wall recurrences should not have previously exceeded more than 450 mg/m2 doxorubicin due to expected cumulative cardiotoxicity. Prior taxane therapy is allowed, however, there should be no reported anaphylactic reactions of grade 3 or higher.
- Age ≥18 years
- ECOG performance status ≤2
Key exclusion criteria (12 listed)
- Patients who have had radiotherapy within 6 months prior to entering the study or those who have not recovered to < grade 2 adverse events due to radiation
- Patients who have experienced a previous grade 3 or 4 anaphylactic reaction to Paclitaxel.
- Patients with grade > 2 neuropathy attributable to previous administration of Taxane chemotherapy.
- Patients who have received prior chemotherapy are allowed, provided they have been off systemic therapy for 21 days and all acute toxicities have resolved to less than grade 2. Patients who have received Paclitaxel within 3 months of study entry and have developed documented progressive disease despite therapy.
- Patients who are receiving any other investigational agents
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 |
|---|---|---|
| Paclitaxel+Initial Radiation+BoostPaclitaxel twice weekly + Initial Fields Radiation + Boost Radiation (10Gy) | Radiation | Paclitaxel+Initial Radiation+Boost |
Primary outcome
MTD identification
Time frame: From first dose at week 1 until unacceptable toxicity occurs, up to 7 weeks
To identify the maximum tolerated dose of twice weekly Paclitaxel given concurrently with chest wall re-irradiation using helical tomotherapy for aggressive breast cancer recurrences
4 secondary outcomes
Time to progression
Time frame: Up to 6 months
Local Control Rate of Dermal Disease at 6 months
Time frame: 6 months
Rate of study-defined grade 1-2 toxicities, and all grade 3 or higher toxicities
Time frame: Up to 6 months
Her-2/neu transformation
Time frame: 1-6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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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.
Jonathan M Feddock, MD principal investigator
UK Markey Cancer Center
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+Initial Radiation+Boost in people with Breast Cancer, run by University of Kentucky 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 14 inclusion and 12 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: withdrawn, as of the sponsor's last update on 15 Nov 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
MTD identification (time frame: From first dose at week 1 until unacceptable toxicity occurs, up to 7 weeks). 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 15 Nov 2016.