Clinical Trials /

Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

NCT02885649

Description:

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.

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Enzalutamide Before Surgery in Treating Patients With Kidney Cancer
  • Official Title: Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE)

Clinical Trial IDs

  • ORG STUDY ID: 081604
  • SECONDARY ID: NCI-2016-01113
  • SECONDARY ID: 081604
  • SECONDARY ID: P30CA072720
  • NCT ID: NCT02885649

Conditions

  • Clear Cell Renal Cell Carcinoma
  • Stage I Renal Cell Cancer

Interventions

DrugSynonymsArms
EnzalutamideASP9785, MDV3100, XtandiTreatment (enzalutamide, nephrectomy)

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (enzalutamide, nephrectomy)ExperimentalPatients receive enzalutamide PO daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy.
  • Enzalutamide

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Cell proliferation
Time Frame:Up to 36 months
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Rutgers, The State University of New Jersey

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