Clinical Trial: Enzalutamide in Patients With Androgen Receptor Positive (AR+) Ovarian, Primary Peritoneal or Fallopian Tube Cancer and One, Two or Three Prior Therapies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Trial of Enzalutamide in Patients With Androgen Receptor Positive (AR+) Ovarian, Primary Peritoneal or Fallopian Tube Cancer and One, Two or Three Prior Therapi

Brief Summary:

This is a Phase II study. The purpose of this study is to find out what effects, good and/or bad enzalutamide has on the patient and the cancer. All patients who enter the study will be closely monitored for side-effects. If multiple patients develop significant side effects from enzalutamide, the study may be stopped early.

Enzalutamide is an androgen-receptor inhibitor, which means that it blocks the activity of the hormone testosterone. In ovarian, fallopian tube, and primary peritoneal cancers that express the androgen receptor, blocking the androgen-receptor may possibly slow or stop tumor growth. Enzalutamide has been studied in women with breast cancer, but this is the first study using enzalutamide for the treatment of patients with ovarian, primary peritoneal, or fallopian tube cancer.


Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome:

  • complete response [ Time Frame: 6 months ]
    by RECIST 1.1 criteria
  • partial response [ Time Frame: 6 months ]
    by RECIST 1.1 criteria


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • adverse events [ Time Frame: every 2 weeks during the first cycle and every 4 weeks during subsequent cycles of treatment ]
    To determine the frequency and severity of adverse events as assessed by NCI CTCAE version 4.0.
  • AR expression levels on tissue [ Time Frame: 2 years ]
    will be determined using standard immunohistochemistry methodology on all tissue and reported as percent tumor cells with nuclear


Original Secondary Outcome: adverse events [ Time Frame: every 2 weeks during the first cycle and every 4 weeks during subsequent cycles of treatment ]

To determine the frequency and severity of adverse events as assessed by NCI CTCAE version 4.0.


Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: October 25, 2013
Date Started: November 2013
Date Completion: October 2018
Last Updated: February 21, 2017
Last Verified: February 2017