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Sponsored by: |
Indiana University School of Medicine |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00393497 |
The purpose of this study is to evaluate the effectiveness of bevacizumab in women with lymphedema as a result of previous treatment for breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Lymphedema |
Drug: bevacizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of VEGF Inhibition in Patients With Lymphedema Following Breast Cancer Treatment |
Estimated Enrollment: | 15 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
The primary objective of this study is:
• To assess the degree of improvement in arm edema as measured by changes in arm volume in patients with ipsilateral lymphedema
The secondary objectives of this study are:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All subjects must have greater than a 3 cm total difference in arm circumference between the affected and unaffected arm measured at five defined points:
Have adequate organ function as specified below:
Exclusion Criteria:
Subjects must not have clinically significant cardiovascular or cerebrovascular disease, including:
Any history of:
Contact: Christy Brown, RN | 317-278-3021 | brown242@iupui.edu |
Contact: Kathy Miller, MD | 317-274-1690 | kathmill@iupui.edu |
United States, Indiana | |
Indiana University Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: LaTrice Vaughn, RN 317-278-3730 lgvaughn@iupui.edu | |
Contact: Anita Rush-Taylor, RN 317-278-6797 arushtay@iupui.edu | |
Principal Investigator: Kathy Miller, MD |
Principal Investigator: | Kathy Miller, MD | Indiana University |
Responsible Party: | Indiana University Cancer Center ( Kathy Miller, MD/ Principal Investigator ) |
Study ID Numbers: | 0606-24, IUCRO-0162 |
Study First Received: | October 26, 2006 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00393497 |
Health Authority: | United States: Food and Drug Administration |
Breast Cancer lymphedema |
Lymphedema Lymphatic Diseases Skin Diseases |
Breast Neoplasms Bevacizumab Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |