Enzalutamide Before Surgery in Treating Patients With Kidney Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:December 5, 2017
End Date:January 2020

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Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE)

This pilot phase 0 trial studies how well enzalutamide works before surgery in treating
patients with kidney cancer. Androgens are a type of hormone produced by the body that may
cause kidney tumors to grow. Anti-hormone therapy, such as enzalutamide, may lessen the
amount of androgens produced by the body and keep kidney tumors from growing.

PRIMARY OBJECTIVES:

I. To investigate the effects of neoadjuvant enzalutamide on clear cell renal cell carcinoma
(ccRCC).

OUTLINE:

Patients receive enzalutamide orally (PO) daily for 90 days in the absence of disease
progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy.

After completion of study treatment, patients are followed up every 3 months.

Inclusion Criteria:

- Clinical T1N0M0 (=< 7 cm) renal mass as measured on cross-sectional imaging (computed
tomography [CT] or magnetic resonance imaging [MRI])

- Biopsy proven ccRCC

- Tumor with androgen receptor (AR) expressed >= 4580 copies/ug ribonucleic acid (RNA)

- Can provide informed consent

- Adequate hepatic function (>= 1.5 x upper limit of normal [ULN]; patient's with
Gilbert's disease are not excluded)

- Adequate renal function (estimated glomerular filtration rate [GFR] > 40mL/min)

- No evidence of metastatic disease on baseline imaging (chest x-ray [CXR] or chest CT,
abdominal CT or MRI)

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Exclusion Criteria:

- Prior use of androgen deprivation including enzalutamide

- Pregnant women or women who are of child bearing age who are not willing to use two
(2) forms of contraception during treatment with enzalutamide and for six (6) months
after treatment

- Men must use adequate methods of contraception during and at least 3 months after
treatment if engaging in sexual activity with a female of child bearing age

- Known hypersensitivity to enzalutamide

- History of unprovoked deep vein thrombosis/pulmonary embolism (DVT/PE) in past twelve
(12) months

- Inability to stop anticoagulants/antiplatelet therapy peri-operatively

- History of seizure or any condition that may predispose to seizure (e.g., prior
cortical stroke or significant brain trauma)

- History of loss of consciousness or transient ischemic attack within twelve (12)
months of enrollment

- Any unstable, serious co-existing medical conditions including but not limited to
myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias,
clinically evident congestive heart failure, or cerebrovascular accident within twelve
(12) months prior to screening

- Known or suspected brain metastasis or active leptomeningeal disease

- Current use of exogenous testosterone

- Retroperitoneal/hilar adenopathy concerning for locally advanced disease

- Metastatic RCC
We found this trial at
1
site
New Brunswick, New Jersey 08903
Principal Investigator: Eric A. Singer
Phone: 732-235-8675
?
mi
from
New Brunswick, NJ
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