A Phase II Trial of Perifosine (IND 58,156; NSC# 639966) in Biochemically Recurrent, Hormone Sensitive Prostate Cancer
PRIMARY OBJECTIVES:
I. To assess the PSA response in prostate cancer patients with only biochemical recurrence
after local curative therapy who are then treated with perifosine.
II. To assess the secondary endpoints of a) six-month increase in PSA levels compared to
baseline, b) PSA doubling time and c) time to PSA progression in prostate cancer patients
receiving perifosine.
III. To evaluate the qualitative and quantitative toxicities of this agent in this patient
population.
IV. To investigate potential molecular markers predictive of decreased PSADT and possibly
PSA response in prostate cancer patients receiving perifosine.
OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy
(surgery vs radiotherapy with or without brachytherapy vs surgery and radiotherapy) and
original combined Gleason score (7 or less vs 8-10).
Patients receive oral perifosine once daily on days 1-28. On day 1 of course 1 only,
patients receive 2 doses of oral perifosine. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone
may receive up to 3 additional courses of therapy after documentation of progression.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA response
Up to 6 years
No
Primo Lara
Principal Investigator
Beckman Research Institute
United States: Food and Drug Administration
NCI-2012-02832
NCT00058214
March 2003
Name | Location |
---|---|
City of Hope | Duarte, California 91010 |