Safety Study of Bevacizumab to Treat Women With a History of Breast Cancer and Suffering From Upper Extremity Lymphedema

Status:

UNKNOWN

Safety Study of Bevacizumab to Treat Women With a History of Breast Cancer and Suffering From Upper Extremity Lymphedema

Lead Sponsor:

Premiere Oncology of Arizona

Collaborating Sponsors:

Genentech, Inc.

Conditions:

Lymphedema

Eligibility:

FEMALE

Phase:

PHASE1

Brief Summary

The purpose of this study is to determine the safety and side effects of bevacizumab in subjects with lymphedema who will initially receive bevacizumab alone and then in combination with standard manu...

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 ...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT00318513

Last Update

May 10 2006

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