A Pilot Study of VEGF Inhibition in Patients With Lymphedema Following Breast Cancer Treatment

NCT00393497 | Completed Phase 1 DMC

• 2 other identifiers: 0606-24IUCRO-0162
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Lymphedema

Keywords

Breast Cancer; lymphedema

Outcome Measures

Primary Outcomes (9)

• Arm Volume

  baseline, Day 1, Day 22, q 6wks, termination

• The affected and unaffected arm measured at five defined points:

  baseline, Day 1, Day 22, q 6wks, termination

• each hand just distal to the thumb

  baseline, Day 1, Day 22, q 6wks, termination

• each wrist at its narrowest point

  baseline, Day 1, Day 22, q 6wks, termination

• each arm 30 cm proximal to the tip of the middle finger

  baseline, Day 1, Day 22, q 6wks, termination

• each arm 40 cm proximal to the tip of the middle finger

  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.)

  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

  baseline, Day 1, Day 22, q 6wks, termination

• Patients will initially be treated for 42 days (6 weeks).

  Day 1-42

Interventions

bevacizumab DRUG

Bevacizumab 15 mg/kg IV every 21 days

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kathy Miller, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2006
• First Posted: October 27, 2006
• Study Start: April 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2011
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

US (1)