Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

NCT ID: NCT02885649

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-05
• Study Completion Date: 2020-03-02

Brief Summary

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.

Detailed Description

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.

Conditions

Clear Cell Renal Cell Carcinoma; Stage I Renal Cell Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (enzalutamide, nephrectomy)

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

Group Type: EXPERIMENTAL

Enzalutamide

Intervention Type: DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Nephrectomy

Intervention Type: PROCEDURE

Undergo partial or radical nephrectomy

Interventions

Enzalutamide

Given PO

Intervention Type: DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Nephrectomy

Undergo partial or radical nephrectomy

Intervention Type: PROCEDURE

Other Intervention Names

ASP9785; MDV3100; Xtandi

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Eric A. Singer, MD, MA, MS, FACS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Singer

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

NCI-2016-01113

Identifier Type: REGISTRY

Identifier Source: secondary_id

081604

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro20170000806

Identifier Type: -

Identifier Source: org_study_id