Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

Early Phase 1

Terminated

• Conditions: Stage I Renal Cell Cancer; Clear Cell Renal Cell Carcinoma
• Interventions: Drug: Enzalutamide; Other: Laboratory Biomarker Analysis; Procedure: Nephrectomy

• Registration Number: NCT02885649
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-31
• Study Start: 2017-12-05
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (enzalutamide, nephrectomy)	Laboratory Biomarker Analysis	Patients receive enzalutamide PO daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy.
Treatment (enzalutamide, nephrectomy)	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.
Treatment (enzalutamide, nephrectomy)	Enzalutamide	Patients receive enzalutamide PO daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy.

Primary Outcome Measures

Name	Time	Method
Cell proliferation	Up to 36 months
Tumor apoptosis as measured by annexin	Up to 36 months

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events version 4	Up to 36 months	Post-operative complications will be documented according to the Clavien-Dindo Classification System.
Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	Up to 36 months

Trial Locations

Locations (1)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States