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A Study of Vascular Endothelial Growth Factor (VEGF) Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00827372
First received: January 20, 2009
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

The major purpose of this study is to determine if a new drug called pazopanib decreases lymphedema in subjects previously treated for cancer. Lymphedema, or swelling of the arm, is a result of damage to the lymphatic vessels in the arm during surgery and/or radiation. The damaged vessels can not adequately drain fluid from the arm, resulting in increased pressure and swelling. Pazopanib has not previously been studied as a treatment for lymphedema.


Condition Intervention Phase
Lymphedema
 Drug: Pazopanib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase II Study of VEGF Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer

Resource links provided by NLM:

Drug Information available for: Pazopanib
U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • To assess the degree of improvement in arm edema as measured by changes in arm volume in patients with ipsilateral lymphedema [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2009
Estimated Study Completion Date: October 2013
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pazopanib Treatment
Pazopanib 800 mg orally once each day (maximum total duration of treatment = 24 weeks)
 Drug: Pazopanib
Pazopanib will be administered at a starting dose of 800 mg orally once each day.
Other Name: GW786034

Detailed Description:

Pazopanib inhibits the growth of blood vessels in tumors by inhibiting a protein called vascular endothelial growth factor (commonly called VEGF). Pazopanib is not currently approved by the US Food and Drug Administration (FDA) and therefore considered an experimental medication.

High levels of VEGF cause blood vessels to leak fluid, increasing the pressure in tumors similar to the increased pressure in lymphedema. Previous studies have found that treatment with pazopanib decreases the fluid pressure in tumors. That is why we think pazopanib might be an effective treatment for lymphedema.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have unilateral lymphedema of the ipsilateral arm attributed to prior surgical treatment or radiation therapy for cancer that is severe enough to warrant therapy in the opinion of the patient and treating physician.
  • All patients must have greater than a 3 cm total difference in arm circumference between the affected and unaffected arm measured at five defined points (see protocol).
  • Be at least 18 years of age
  • Have adequate organ function as specified in the protocol.
  • Agree to use effective contraceptive methods during the course of the study if the patient has child-producing potential
  • Have an ECOG performance status of 0 or 1

Exclusion Criteria:

  • Pregnant, lactating, or unwilling to use appropriate birth control
  • Active infection
  • Patients may not have clinically significant cardiovascular disease including myocardial infarction within 6 months prior to initiation of therapy, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, grade II or greater peripheral vascular disease, uncontrolled hypertension defined as SBP>160 or DBP>90. Patients may not have any prior history of cerebrovascular disease including TIA or stroke.
  • Locally recurrent or metastatic disease
  • Concurrent therapeutic anticoagulation or any history of DVT or PE.
  • Major surgery within 4 weeks of starting protocol therapy (non-operative biopsy or placement of a vascular access device is not considered major surgery)
  • Radiation therapy or chemotherapy within the past 6 weeks or currently undergoing radiation therapy or chemotherapy (Concurrent adjuvant hormonal therapy is allowed.)
  • Altered the physical therapy regimen within the past month
  • Indwelling venous device in the ipsilateral arm
  • Bilateral lymphedema
  • Concomitant requirement for medication classified as substrates for the CYP450 enzymes and listed as prohibited in the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827372

Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Kathy Miller, MD IU Simon Cancer Center
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00827372     History of Changes
Other Study ID Numbers: 0811-15 /IUCRO-0248
Study First Received: January 20, 2009
Last Updated: October 15, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases
Endothelial Growth Factors
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013