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Enzalutamide and Indomethacin in Treating Patients With Recurrent or Metastatic Hormone-Resistant Prostate Cancer

2016-10-18 02:08:21 | BioPortfolio

Summary

This phase I/II trial studies the side effects of enzalutamide and indomethacin and to see how well they work in treating patients with prostate cancer that does not respond to treatment with hormones, has come back, or has spread from where it started to other places in the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells.

Description

PRIMARY OBJECTIVES:

I. To assess the toxicity of indomethacin and enzalutamide when given in combination, and to determine the prostate-specific antigen (PSA) response that is defined as a 50% or more reduction from the baseline.

SECONDARY OBJECTIVES:

I. To determine the overall response as determined by the Prostate Cancer Working Group 2 criteria (PCWG2).

II. To evaluate the progression-free survival (PFS) and overall survival of castration-resistant prostate cancer (CRPC) patients treated with indomethacin and enzalutamide.

III. To evaluate molecular correlatives for patient response and outcomes through the analysis of patient baseline tumor specimens (diagnostic biopsy) along with serial blood specimens.

OUTLINE:

Patients receive enzalutamide orally (PO) once daily (QD) and indomethacin PO twice daily (BID) or QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Metastatic Prostate Carcinoma

Intervention

Enzalutamide, Indomethacin

Location

University of California Davis Comprehensive Cancer Center
Sacramento
California
United States
95817

Status

Not yet recruiting

Source

University of California, Davis

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-18T02:08:21-0400

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