A Study of Vascular Endothelial Growth Factor (VEGF) Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer
Condition: Lymphedema
MeSH terms: Lymphedema
Intervention: Pazopanib
Intervention description: Pazopanib will be administered at a starting dose of 800 mg orally once each day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.