Vorinostat in Treating Patients With Progressive Metastatic Prostate Cancer

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00330161
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • vorinostat — DRUG
    Given orally
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase II trial is studying how well vorinostat works in treating patients with progressive metastatic prostate cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Mar 31, 2006
Status verified
Dec 2012
Primary completion
Sep 30, 2009
Completion
May 31, 2011

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (vorinostat)
    Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity. Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.

Primary Outcome Measure

Proportion of Patients Who do Not Demonstrate Disease Progression [ Time Frame: At 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109-

Find similar trials in Ann Arbor, MI

By research site
University of Michigan· Ann Arbor, MI

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