Phase 2
N=10
A Study of Vascular Endothelial Growth Factor (VEGF) Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer
Lymphedema
Bottom Line
View on ClinicalTrials.gov: NCT00827372 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Change in Volume Ipsilateral Lymphedema in Arm — -161.0; -372.8 mL — p=0.0658
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pazopanib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kathy Miller
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Volume Ipsilateral Lymphedema in Arm |
-161.0; -372.8 | 0.0658 |
| SECONDARY Changes in Interstitial Fluid Pressure (ECF Volume) in the Arm |
-0.76 | 0.0061 sig |
| SECONDARY Change in Impedance or ECF Volume in the Arm |
1.39; 1.43; 1.46 | 0.0143 sig |
| SECONDARY Number of Patients With Trt Related Grade 2+ AEs |
9; 7 | — |
| SECONDARY Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions) |
25.3; 24.9; 22.9; 21.2; 25.2; 119.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00827372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.