Breast CancerPhase 1NCT00393497
A Pilot Study of VEGF Inhibition in Patients With Lymphedema Following Breast Cancer Treatment
A Phase 1 study testing bevacizumab in people with Breast Cancer and Lymphedema, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of bevacizumab in women with lymphedema as a result of previous treatment for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jan 2011
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have unilateral lymphedema of the ipsilateral arm attributed to prior surgical treatment or radiation therapy for breast cancer that is severe enough to warrant therapy in the opinion of the subject and treating physician.
- All subjects must have greater than a 3 cm total difference in arm circumference between the affected and unaffected arm measured at five defined points:
- each hand just distal to the thumb
- each wrist at its narrowest point
- each arm 30 cm proximal to the tip of the middle finger
- each arm 40 cm proximal to the tip of the middle finger
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- each arm 50 cm proximal to the tip of the middle finger (if possible before the axilla is reached.)
- Be at least 18 years of age
- Have adequate organ function as specified below:
- AST and ALT less than or equal to 2.0 times ULN
- Total bilirubin less than or equal to 1.5 mg/dL
- Serum creatinine less than or equal to 1.5 mg/dL
- Urine protein:creatinine ratio < 1.0*
- LVEF > institutional limits of normal by MUGA or ECHO
- PT INR < 1.5; PTT < 1.5 x normal
- Absolute neutrophil count greater than or equal to 1000/mm3
- Platelets greater than or equal to 100,000/mm3
- Agree to use effective contraceptive methods during the course of the study if the subject has child-producing potential
- Have an ECOG performance status of 0 or 1
Who cannot join
- Subjects must not be pregnant, lactating, or refuse to use appropriate birth control
- Subjects must not have an active infection requiring parenteral or oral antibiotics
- Subjects must not have clinically significant cardiovascular or cerebrovascular disease, including:
- Any history of:
- Cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage
- Ischemic bowel
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- Hypertensive crisis or hypertensive encephalopathy Within the last 12 months
- Myocardial infarction
- Unstable angina
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Grade II or greater peripheral vascular disease
- DVT or PE Active at study entry
- Uncontrolled hypertension defined as SBP > 150 or DBP > 100
- Uncontrolled or clinically significant arrhythmia.
- Subjects may not have locally recurrent or metastatic disease
- Subjects may not require concurrent therapeutic anticoagulation. (NOTE: Prophylactic doses of coumadin to maintain patency of a vascular access device is allowed). In addition, subjects with a bleeding diathesis are excluded.
- Subjects may not have had major surgery within 4 weeks of starting protocol therapy (NOTE: Placement of a vascular access device is not considered major surgery)
- Subjects may not have received radiation therapy, chemotherapy or trastuzumab within the past 6 weeks (NOTE: Concurrent adjuvant hormonal therapy is allowed.)
- Subjects may not have altered the physical therapy regimen for lymphedema within the past month
- Subjects may not have an indwelling venous device in the ipsilateral arm
- Subjects may not have bilateral lymphedema
- Subjects may not have a non-healing wound, ulcer or bone fracture.
- Subjects may not have a known hypersensitivity to any component of Bevacizumab
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Cancer Center
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to evaluate the effectiveness of bevacizumab in women with lymphedema as a result of previous treatment for breast cancer.
Read the detailed description
The primary objective of this study is:
- To assess the degree of improvement in arm edema as measured by changes in arm volume in patients with ipsilateral lymphedema
The secondary objectives of this study are:
- To assess the degree of improvement in arm edema as measured by changes in arm interstitial fluid pressure (IFP)
- To assess the degree of improvement in arm edema as measured by changes in extracellular fluid (ECF) volume based on bioelectrical impedance analysis (BIA) by lymphometer
- To assess the safety and tolerability of VEGF inhibition in this patient population
- To assess the clinical benefit in patients with ipsilateral lymphedema treated with vascular endothelial growth factor (VEGF) inhibition by evaluating patient responses to a quality of life questionnaire (FACT-B+4 lymphedema questions)
- To determine the impact of VEGF inhibition on circulating VEGF levels in patients with lymphedema
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- bevacizumab
- Keywords
- Breast Cancer, lymphedema
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Bevacizumab 15 mg/kg IV every 21 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Volume
Measured: baseline, Day 1, Day 22, q 6wks, termination
The affected and unaffected arm measured at five defined points:
Measured: baseline, Day 1, Day 22, q 6wks, termination
each hand just distal to the thumb
Measured: baseline, Day 1, Day 22, q 6wks, termination
each wrist at its narrowest point
Measured: baseline, Day 1, Day 22, q 6wks, termination
each arm 30 cm proximal to the tip of the middle finger
Measured: baseline, Day 1, Day 22, q 6wks, termination
each arm 40 cm proximal to the tip of the middle finger
Measured: baseline, Day 1, Day 22, q 6wks, termination
each arm 50 cm proximal to the tip of the middle finger (if possible before the axilla is reached.)
Measured: baseline, Day 1, Day 22, q 6wks, termination
The volume of each arm will be calculated from these measurements using the Casley Smith method29. Treatment will be considered efficacious if there is a greater than or equal to 25% decrease in excess arm volume (affected arm volume minus unaffected arm
Measured: baseline, Day 1, Day 22, q 6wks, termination
Patients will initially be treated for 42 days (6 weeks).
Measured: Day 1-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2006 (estimated)
- Study startApr 2007
- Primary completionOct 2009
- Study completionJan 2011
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 Indiana UniversityThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathy Miller, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393497
- Sponsor's protocol ID
- 0606-24
- Other IDs
- IUCRO-0162
- Status last verified
- Sep 2014
- First submitted
- 26 Oct 2006
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of VEGF Inhibition in Patients With Lymphedema Following Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT00393497
- Acronym / sponsor ID
- 0606-24
- Conditions
- Breast Cancer, Lymphedema
- Keywords
- Breast Cancer, lymphedema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 27 Oct 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 evaluate the effectiveness of bevacizumab in women with lymphedema as a result of previous treatment for breast cancer.
Detailed description
The primary objective of this study is:
- To assess the degree of improvement in arm edema as measured by changes in arm volume in patients with ipsilateral lymphedema
The secondary objectives of this study are:
- To assess the degree of improvement in arm edema as measured by changes in arm interstitial fluid pressure (IFP)
- To assess the degree of improvement in arm edema as measured by changes in extracellular fluid (ECF) volume based on bioelectrical impedance analysis (BIA) by lymphometer
- To assess the safety and tolerability of VEGF inhibition in this patient population
- To assess the clinical benefit in patients with ipsilateral lymphedema treated with vascular endothelial growth factor (VEGF) inhibition by evaluating patient responses to a quality of life questionnaire (FACT-B+4 lymphedema questions)
- To determine the impact of VEGF inhibition on circulating VEGF levels in patients with lymphedema
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
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Have unilateral lymphedema of the ipsilateral arm attributed to prior surgical treatment or radiation therapy for breast cancer that is severe enough to warrant therapy in the opinion of the subject and treating physician.
- All subjects must have greater than a 3 cm total difference in arm circumference between the affected and unaffected arm measured at five defined points:
- Be at least 18 years of age
- Have adequate organ function as specified below:
- Agree to use effective contraceptive methods during the course of the study if the subject has child-producing potential
Key exclusion criteria (23 listed)
- Subjects must not be pregnant, lactating, or refuse to use appropriate birth control
- Subjects must not have an active infection requiring parenteral or oral antibiotics
- Subjects must not have clinically significant cardiovascular or cerebrovascular disease, including:
- Subjects may not have locally recurrent or metastatic disease
- Subjects may not require concurrent therapeutic anticoagulation. (NOTE: Prophylactic doses of coumadin to maintain patency of a vascular access device is allowed). In addition, subjects with a bleeding diathesis are excluded.
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 |
|---|---|---|
| bevacizumabBevacizumab 15 mg/kg IV every 21 days | Drug | – |
Primary outcome
Arm Volume
Time frame: baseline, Day 1, Day 22, q 6wks, termination
The affected and unaffected arm measured at five defined points:
Time frame: baseline, Day 1, Day 22, q 6wks, termination
each hand just distal to the thumb
Time frame: baseline, Day 1, Day 22, q 6wks, termination
each wrist at its narrowest point
Time frame: baseline, Day 1, Day 22, q 6wks, termination
each arm 30 cm proximal to the tip of the middle finger
Time frame: baseline, Day 1, Day 22, q 6wks, termination
each arm 40 cm proximal to the tip of the middle finger
Time frame: baseline, Day 1, Day 22, q 6wks, termination
each arm 50 cm proximal to the tip of the middle finger (if possible before the axilla is reached.)
Time frame: baseline, Day 1, Day 22, q 6wks, termination
The volume of each arm will be calculated from these measurements using the Casley Smith method29. Treatment will be considered efficacious if there is a greater than or equal to 25% decrease in excess arm volume (affected arm volume minus unaffected arm
Time frame: baseline, Day 1, Day 22, q 6wks, termination
Patients will initially be treated for 42 days (6 weeks).
Time frame: Day 1-42
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 22 Sep 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.
Kathy Miller, MD principal investigator
Indiana University
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 bevacizumab in people with Breast Cancer and Lymphedema, run by Indiana University 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 19 inclusion and 23 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 22 Sep 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?
Arm Volume (time frame: baseline, Day 1, Day 22, q 6wks, termination). The study lists 9 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 22 Sep 2014.