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

NCT ID: NCT00827372

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-07-31

Brief Summary

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.

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.

Conditions

Lymphedema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pazopanib Treatment

Pazopanib 800 mg orally once each day (maximum total duration of treatment = 24 weeks)

Group Type: EXPERIMENTAL

Pazopanib

Intervention Type: DRUG

Pazopanib will be administered at a starting dose of 800 mg orally once each day.

Interventions

Pazopanib

Pazopanib will be administered at a starting dose of 800 mg orally once each day.

Intervention Type: DRUG

Other Intervention Names

GW786034

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kathy Miller

OTHER

Sponsor Role: lead

Responsible Party

Kathy Miller

Ballvé-Lantero Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kathy Miller, MD

Role: PRINCIPAL_INVESTIGATOR

IU Simon Cancer Center

Locations

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0811-15 /IUCRO-0248

Identifier Type: -

Identifier Source: org_study_id