A Phase II Study of VEGF Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer
18 Years
N/A
Both
Lymphedema
Trial Information
A Phase II Study of VEGF Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
To assess the degree of improvement in arm edema as measured by changes in arm volume in patients with ipsilateral lymphedema
Outcome Time Frame:
24 weeks
Safety Issue:
No
Principal Investigator
Kathy Miller, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
IU Simon Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
0811-15 /IUCRO-0248
NCT ID:
NCT00827372
Start Date:
January 2009
Completion Date:
October 2013
Related Keywords:
- Lymphedema
- Lymphedema
Name | Location |
|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
