Clinical Trial: Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Hormone Therapy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Pilot Study of Vorinostat to Restore Sensitivity to Aromatase Inhibitor Therapy Part B

Brief Summary: This pilot clinical trial studies vorinostat in treating patients with stage IV breast cancer receiving hormone therapy. Vorinostat may help hormone therapy work better by making tumor cells more sensitive to the drug.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Estimate the rate of clinical benefit (objective response plus stable disease) for patients treated with 28-day cycles of vorinostat (first 5 consecutive days each week for day 1-21) concurrent with daily aromatase inhibitor (AI) therapy (all 28 days).

SECONDARY OBJECTIVES:

I. Assess the safety and tolerability of vorinostat and AI combination therapy in patients with metastatic breast cancer.

II. Assess the change in estrogen receptor (ER) expression, measured as the change in F-18 16 alpha-fluoroestradiol (FES) standardized uptake value (SUV) using FES positron emission tomography (PET) completed per protocol 7184 after two weeks of vorinostat and AI therapy and after 8 weeks of therapy.

III. Assess tumor metabolic response, measured as the change in fludeoxyglucose F 18 (FDG) SUV using FDG PET completed per protocol 7184 after two weeks of vorinostat and AI therapy and after 8 weeks of therapy.

IV. Assess the change in hormone levels (estradiol, estrone, follicle-stimulating hormone [FSH], sex binding globulin, testosterone, and free testosterone) after 8 weeks of therapy.

V. Assess the change in ER, progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), androgen receptor (AR), epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF) tumor expression after two weeks of vorinostat and AI therapy in patients that consent to optional tissue biopsy procedure.

VI. Assess the time to progression and the overall survival of patients treated with 28-day cycles of
Sponsor: University of Washington

Current Primary Outcome:

  • Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST [ Time Frame: 8 weeks ]

    A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit.

    Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more).

  • Response Rate According to RECIST [ Time Frame: 8 weeks ]

    A 90% score (Wilson) confidence interval will be computed for the response rate.

    Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more).



Original Primary Outcome:

  • Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST [ Time Frame: Up to 5 years ]
    A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit.
  • Response Rate According to RECIST [ Time Frame: Up to 5 years ]
    A 90% score (Wilson) confidence interval will be computed for the response rate.


Current Secondary Outcome:

  • Duration of Response [ Time Frame: Up to 5 years ]
    Duration of response will be summarized for responders.
  • Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]
    Kaplan-Meier survival curves will be used to describe PFS.
  • Overall Survival [ Time Frame: Up to 5 years ]
    Kaplan-Meier survival curves will be used to describe overall survival.


Original Secondary Outcome: Same as current

Information By: University of Washington

Dates:
Date Received: October 31, 2012
Date Started: November 2012
Date Completion: December 2017
Last Updated: November 4, 2016
Last Verified: November 2016