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

NCT00827372 | Completed Phase 2 Results DMC

• 1 other identifier: 0811-15 /IUCRO-0248
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• Change in Volume Ipsilateral Lymphedema in Arm

  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).

  Baseline through Cycle 6, Day 1

Secondary Outcomes (4)

• 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

Study Arms (1)

Pazopanib Treatment

EXPERIMENTAL

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

Drug: Pazopanib

Interventions

Pazopanib DRUG

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

Also known as: GW786034

Pazopanib Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kathy Miller: lead

Study Sites (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Lymphedema

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

This study was to enroll 14-15 patients. Due to toxicity and enough patients met the definition of response, enrollment to this study was halted early, leading to a smaller number of subjects analyzed.

Results Point of Contact

• Title: Kathy Miller, MD
• Organization: IndianaU

kathmill@iupui.edu

317-944-0920

Study Officials

• Kathy Miller, MD

  IU Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ballvé-Lantero Professor of Medicine

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 16, 2023
• Results First Posted: October 16, 2014

Record last verified: 2023-10

Locations

US (1)