- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318513
Safety Study of Bevacizumab to Treat Women With a History of Breast Cancer and Suffering From Upper Extremity Lymphedema
Phase I Study Evaluating the Safety of Bevacizumab in Women With a History of Breast Cancer Suffering From Moderate to Severe Upper Extremity Lymphedema
Study Overview
Detailed Description
Lymphedema occurs with varying frequency in patients with cancer but approximately 10-15% of all breast cancer patients will develop lymphedema following breast cancer treatment. Lymphedema in breast cancer patients following axillary lymph node dissection is caused by the interruption of the axillary lymphatic system by surgery or radiation therapy, which causes an accumulation of fluid in the subcutaneous tissue of the arm, with decreased distensibility of tissue around the joints and increased weight of the extremity. The primary current therapy employed involves complete decongestive therapy (CDT) which encompasses the use of manual lymphatic drainage (MLD) and compression bandaging (CB) to the affected limb.
The specific contribution of the vascular system to the development of lymphedema is unclear. Vascular permeability is a complex process which is primarily controlled by the interaction of the ligand vascular endothelial growth factor (VEGF). As a result of the understanding of the biology of VEGF and the anecdotal appreciation of women with lymphedema who have noted improvement in their lymphedema while on VEGF inhibitor therapy, it is hypothesized that the reduction in vascular permeability resulting from the use of a VEGF inhibitor either alone or in conjunction with standard decongestive lymphedema therapy may significantly improve the outcome for patients with this post-operative complication.
Bevacizumab is a recombinant humanized monoclonal antibody directed against VEGF. Bevacizumab blocks the development of new blood vessels in cancer and it is approved by the FDA for the treatment of colon cancer in combination with chemotherapy. While bevacizumab has been administered to thousands of patients with cancer, there is only limited information about the use of bevacizumab in subjects without active cancer.
This study will evaluate the safety profile of escalating doses of bevacizumab administered intravenously alone for 4 weeks followed by 4 weeks of therapy in combination with manual lymph drainage (MLD) and compression bandaging (CB) to patients with moderate to severe unilateral upper extremity lymphedema due to prior breast cancer therapy.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85260
- Premiere Oncology of Arizona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women with a history of breast cancer status post (s/p) prior surgical resection (i.e., either lumpectomy and radiation, modified radical mastectomy or radical mastectomy) with lymphedema defined as a difference in limb volume of at least 500 ml by perometric assessment
- Lymphedema may be newly diagnosed or previously treated as long as it is Stage I (pitting) or II (fibrosis) at the time of study entry.
- No known evidence of recurrent or active metastatic breast cancer
- No prior chemotherapy within 6 months of study entry and has recovered to grade 1 or less from the toxicity of all prior chemotherapy or radiation therapy (with the exception of alopecia); ongoing anti-estrogen therapy for post-menopausal survivors is permissible.
- Normal end organ function defined as: serum creatinine < 1.5 mg/dl or a calculated creatinine clearance > 50 ml/min; SGOT and SGPT < 2.5 X upper limit of normal (ULN); total bilirubin < 1.5 X ULN; absolute neutrophil count (ANC) > 1,500 cells/µl; hemoglobin > 10 g/dl (without transfusions); platelet count > 100,000/µl; serum albumin within normal limits (WNL).
Exclusion Criteria:
- Stage III (lymphostatic elephantiasis) lymphedema
- Clinical evidence of bilateral lymphedema. Those patients who have undergone bilateral breast cancer surgery or prophylactic mastectomy on the non-cancerous breast will be excluded.
- Any prior history of deep venous thrombosis (DVT) or pulmonary embolus (with the exception of prior line-related thrombotic events) or myocardial infarction (MI), cerebrovascular accident (CVA) or any other arterial thromboembolic event (i.e., transient ischemic attack [TIA], reversible ischemic neurologic deficit [RIND], history of angina pectoris, clinically significant peripheral vascular disease with claudication, etc.)
- Patients with problems with wound healing (e.g., diabetic ulcers), gastrointestinal fistula
- Patients receiving therapeutic anti-coagulation including full dose aspirin or non-steroidal anti-inflammatory agents known to inhibit platelet function (low dose coumadin for port prophylaxis and low dose aspirin are allowed)
- Untreated hypertension with a baseline systolic blood pressure (SBP) of > 150 mmHg or a diastolic blood pressure (DBP) >100 mmHg will be excluded (stable treated hypertension with values less than those noted will be eligible).
- A history of infectious complications of the involved arm or those with any contraindication to MLD + CB [e.g., congestive heart failure (CHF), DVT, acute or chronic renal failure] will be excluded.
- Women with a history of CHF [New York Heart Association (NYHA) Class II or greater] will be excluded.
- Pregnant or breast-feeding
- Unwilling to use an appropriate form of barrier contraception for the duration of the study and for three months following the last dose of bevacizumab
- Those patients who are actively undergoing MLD and/or CB at the time of study entry and for up to 4 weeks prior to entry
- Unable to provide written informed consent or to comply with study procedures
- Baseline urine protein : creatinine ratio > 1.0
- Known evidence of a bleeding diathesis or coagulopathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael S Gordon, MD, Premiere Oncology of Arizona
Publications and helpful links
General Publications
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- Johansson K, Lie E, Ekdahl C, Lindfeldt J. A randomized study comparing manual lymph drainage with sequential pneumatic compression for treatment of postoperative arm lymphedema. Lymphology. 1998 Jun;31(2):56-64.
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- Mellor RH, Bush NL, Stanton AW, Bamber JC, Levick JR, Mortimer PS. Dual-frequency ultrasound examination of skin and subcutis thickness in breast cancer-related lymphedema. Breast J. 2004 Nov-Dec;10(6):496-503. doi: 10.1111/j.1075-122X.2004.21458.x.
- Brown LF, Yeo KT, Berse B, Yeo TK, Senger DR, Dvorak HF, van de Water L. Expression of vascular permeability factor (vascular endothelial growth factor) by epidermal keratinocytes during wound healing. J Exp Med. 1992 Nov 1;176(5):1375-9. doi: 10.1084/jem.176.5.1375.
- Dvorak HF, Brown LF, Detmar M, Dvorak AM. Vascular permeability factor/vascular endothelial growth factor, microvascular hyperpermeability, and angiogenesis. Am J Pathol. 1995 May;146(5):1029-39.
- Dvorak HF. Vascular permeability factor/vascular endothelial growth factor: a critical cytokine in tumor angiogenesis and a potential target for diagnosis and therapy. J Clin Oncol. 2002 Nov 1;20(21):4368-80. doi: 10.1200/JCO.2002.10.088.
- Yoshiji H, Kuriyama S, Hicklin DJ, Huber J, Yoshii J, Ikenaka Y, Noguchi R, Nakatani T, Tsujinoue H, Fukui H. The vascular endothelial growth factor receptor KDR/Flk-1 is a major regulator of malignant ascites formation in the mouse hepatocellular carcinoma model. Hepatology. 2001 Apr;33(4):841-7. doi: 10.1053/jhep.2001.23312.
- Yuan F, Chen Y, Dellian M, Safabakhsh N, Ferrara N, Jain RK. Time-dependent vascular regression and permeability changes in established human tumor xenografts induced by an anti-vascular endothelial growth factor/vascular permeability factor antibody. Proc Natl Acad Sci U S A. 1996 Dec 10;93(25):14765-70. doi: 10.1073/pnas.93.25.14765.
- Infanger M, Schmidt O, Kossmehl P, Grad S, Ertel W, Grimm D. Vascular endothelial growth factor serum level is strongly enhanced after burn injury and correlated with local and general tissue edema. Burns. 2004 Jun;30(4):305-11. doi: 10.1016/j.burns.2003.12.006.
- Goto T, Fujigaki Y, Sun DF, Yamamoto T, Hishida A. Plasma protein extravasation and vascular endothelial growth factor expression with endothelial nitric oxide synthase induction in gentamicin-induced acute renal failure in rats. Virchows Arch. 2004 Apr;444(4):362-74. doi: 10.1007/s00428-004-0977-5. Epub 2004 Feb 24.
- Leduc O, Leduc A, Bourgeois P, Belgrado JP. The physical treatment of upper limb edema. Cancer. 1998 Dec 15;83(12 Suppl American):2835-9. doi: 10.1002/(sici)1097-0142(19981215)83:12b+3.0.co;2-v.
- Casley-Smith JR, Boris M, Weindorf S, Lasinski B. Treatment for lymphedema of the arm--the Casley-Smith method: a noninvasive method produces continued reduction. Cancer. 1998 Dec 15;83(12 Suppl American):2843-60. doi: 10.1002/(sici)1097-0142(19981215)83:12b+3.3.co;2-l.
- Loprinzi CL, Kugler JW, Sloan JA, Rooke TW, Quella SK, Novotny P, Mowat RB, Michalak JC, Stella PJ, Levitt R, Tschetter LK, Windschitl H. Lack of effect of coumarin in women with lymphedema after treatment for breast cancer. N Engl J Med. 1999 Feb 4;340(5):346-50. doi: 10.1056/NEJM199902043400503.
- Ueda Y, Yamagishi T, Samata K, Ikeya H, Hirayama N, Okazaki T, Nishihara S, Arai K, Yamaguchi S, Shibuya M, Nakaike S, Tanaka M. A novel low molecular weight VEGF receptor-binding antagonist, VGA1102, inhibits the function of VEGF and in vivo tumor growth. Cancer Chemother Pharmacol. 2004 Jul;54(1):16-24. doi: 10.1007/s00280-004-0763-8. Epub 2004 Apr 3.
- Checkley D, Tessier JJ, Kendrew J, Waterton JC, Wedge SR. Use of dynamic contrast-enhanced MRI to evaluate acute treatment with ZD6474, a VEGF signalling inhibitor, in PC-3 prostate tumours. Br J Cancer. 2003 Nov 17;89(10):1889-95. doi: 10.1038/sj.bjc.6601386.
- Folkman J. Seminars in Medicine of the Beth Israel Hospital, Boston. Clinical applications of research on angiogenesis. N Engl J Med. 1995 Dec 28;333(26):1757-63. doi: 10.1056/NEJM199512283332608. No abstract available.
- Weidner N, Semple JP, Welch WR, Folkman J. Tumor angiogenesis and metastasis--correlation in invasive breast carcinoma. N Engl J Med. 1991 Jan 3;324(1):1-8. doi: 10.1056/NEJM199101033240101.
- Borgstrom P, Hillan KJ, Sriramarao P, Ferrara N. Complete inhibition of angiogenesis and growth of microtumors by anti-vascular endothelial growth factor neutralizing antibody: novel concepts of angiostatic therapy from intravital videomicroscopy. Cancer Res. 1996 Sep 1;56(17):4032-9.
- Hu L, Hofmann J, Zaloudek C, Ferrara N, Hamilton T, Jaffe RB. Vascular endothelial growth factor immunoneutralization plus Paclitaxel markedly reduces tumor burden and ascites in athymic mouse model of ovarian cancer. Am J Pathol. 2002 Nov;161(5):1917-24. doi: 10.1016/S0002-9440(10)64467-7.
- Yang JC, Haworth L, Sherry RM, Hwu P, Schwartzentruber DJ, Topalian SL, Steinberg SM, Chen HX, Rosenberg SA. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med. 2003 Jul 31;349(5):427-34. doi: 10.1056/NEJMoa021491.
- Ostendorf T, Kunter U, Eitner F, Loos A, Regele H, Kerjaschki D, Henninger DD, Janjic N, Floege J. VEGF(165) mediates glomerular endothelial repair. J Clin Invest. 1999 Oct;104(7):913-23. doi: 10.1172/JCI6740.
- Shen BQ, Lee DY, Gerber HP, Keyt BA, Ferrara N, Zioncheck TF. Homologous up-regulation of KDR/Flk-1 receptor expression by vascular endothelial growth factor in vitro. J Biol Chem. 1998 Nov 6;273(45):29979-85. doi: 10.1074/jbc.273.45.29979.
- Dvorak HF, Nagy JA, Feng D, Brown LF, Dvorak AM. Vascular permeability factor/vascular endothelial growth factor and the significance of microvascular hyperpermeability in angiogenesis. Curr Top Microbiol Immunol. 1999;237:97-132. doi: 10.1007/978-3-642-59953-8_6.
- Dvorak AM, Kohn S, Morgan ES, Fox P, Nagy JA, Dvorak HF. The vesiculo-vacuolar organelle (VVO): a distinct endothelial cell structure that provides a transcellular pathway for macromolecular extravasation. J Leukoc Biol. 1996 Jan;59(1):100-15.
- Feng D, Nagy JA, Pyne K, Hammel I, Dvorak HF, Dvorak AM. Pathways of macromolecular extravasation across microvascular endothelium in response to VPF/VEGF and other vasoactive mediators. Microcirculation. 1999 Mar;6(1):23-44.
- Feng D, Nagy JA, Hipp J, Pyne K, Dvorak HF, Dvorak AM. Reinterpretation of endothelial cell gaps induced by vasoactive mediators in guinea-pig, mouse and rat: many are transcellular pores. J Physiol. 1997 Nov 1;504 ( Pt 3)(Pt 3):747-61. doi: 10.1111/j.1469-7793.1997.747bd.x.
- Tulpule A, Scadden DT, Espina BM, Cabriales S, Howard W, Shea K, Gill PS. Results of a randomized study of IM862 nasal solution in the treatment of AIDS-related Kaposi's sarcoma. J Clin Oncol. 2000 Feb;18(4):716-23. doi: 10.1200/JCO.2000.18.4.716.
- Granato AM, Nanni O, Falcini F, Folli S, Mosconi G, De Paola F, Medri L, Amadori D, Volpi A. Basic fibroblast growth factor and vascular endothelial growth factor serum levels in breast cancer patients and healthy women: useful as diagnostic tools? Breast Cancer Res. 2004;6(1):R38-45. doi: 10.1186/bcr745. Epub 2003 Nov 25.
- Hoar FJ, Lip GY, Belgore F, Stonelake PS. Circulating levels of VEGF-A, VEGF-D and soluble VEGF-A receptor (sFIt-1) in human breast cancer. Int J Biol Markers. 2004 Jul-Sep;19(3):229-35. doi: 10.1177/172460080401900308.
- Malamitsi-Puchner A, Tziotis J, Tsonou A, Protonotariou E, Sarandakou A, Creatsas G. Changes in serum levels of vascular endothelial growth factor in males and females throughout life. J Soc Gynecol Investig. 2000 Sep-Oct;7(5):309-12.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVF3251s
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