Bevacizumab in Breast Cancer and Lymphedema - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: bevacizumab

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 Type

Interventional

Enrollment (Actual)

11

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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
- 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

Exclusion Criteria:

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
- 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Arm Volume Time Frame: baseline, Day 1, Day 22, q 6wks, termination	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	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	baseline, Day 1, Day 22, q 6wks, termination
each wrist at its narrowest point Time Frame: baseline, Day 1, Day 22, q 6wks, termination	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	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	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	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	baseline, Day 1, Day 22, q 6wks, termination
Patients will initially be treated for 42 days (6 weeks). Time Frame: Day 1-42	Day 1-42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

October 26, 2006

First Submitted That Met QC Criteria