A Phase II Study of VEGF Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Kathy Miller
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Volume Ipsilateral Lymphedema in Arm
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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>
- •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.
研究组 & 干预措施
Pazopanib Treatment
Pazopanib 800 mg orally once each day (maximum total duration of treatment = 24 weeks)
干预措施: Pazopanib (Drug)
结局指标
主要结局
Change in Volume Ipsilateral Lymphedema in Arm
时间窗: Baseline through Cycle 6, Day 1
The primary endpoint will be change in excess arm volume (affected arm volume minus unaffected arm volume) compared to baseline. This will be done at Cycle 2 (29 days) and Cycle 6 (174 days).
次要结局
- Changes in Interstitial Fluid Pressure (ECF Volume) in the Arm(First 24 hours after drug was administered)
- Change in Impedance or ECF Volume in the Arm(Baseline, and Cycle 2, Day 1)
- Number of Patients With Trt Related Grade 2+ AEs(End of Treatment)
- Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions)(Baseline through Cycle 6, Day 1)
研究者
Kathy Miller
Ballvé-Lantero Professor of Medicine
Indiana University