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A Phase II Trial of Perifosine (IND 58,156; NSC# 639966) in Biochemically Recurrent, Hormone Sensitive Prostate Cancer

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer

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Trial Information

A Phase II Trial of Perifosine (IND 58,156; NSC# 639966) in Biochemically Recurrent, Hormone Sensitive Prostate Cancer


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

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.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed adenocarcinoma of the

- Patients must have a rising PSA >= 2.0 following a nadir after local curative therapy
(either radical prostatectomy and/or pelvic radiation) with no clinical or
radiographic evidence of metastatic disease; PSA >= 2.0 elevation must be confirmed
by two consecutive increases, each measured at least 2 weeks apart; only patients
with a biochemical (PSA) recurrence with no physical exam or radiographic evidence of
local or distant relapse are eligible

- Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as
long as neither lasted for more than 9 months; androgen deprivation therapy must have
been completed at least one year prior to registration; patients could not have had a
rising PSA at the time that neoadjuvant or adjuvant therapy was stopped

- Life expectancy of greater than 3 months

- Karnofsky performance status > 60%

- Leukocytes >= 3,000/uL

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 100,00/uL

- Total bilirubin =< 1.5 mg/dL

- AST (SGOT)/ALT (SGPT) =< 2.5 x institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min

- Computed tomography scan or MRI of the pelvis negative for metastatic disease within
3 months prior to registration

- Bone scan negative for metastatic disease within 3 months prior to registration

- Chest PA and lateral films negative for metastatic disease within 3 months prior to

- Prior vaccine therapy is allowed if completed at least 6 months prior to registration

- Men enrolled in this trial must agree to use adequate contraception prior to study
entry and for the duration of study participation

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had any prior cytotoxic chemotherapy

- Patients may not be receiving any other investigational agents

- Patients receiving concurrent chemotherapeutic agents, biological response modifiers,
radiation therapy, corticosteroid or hormonal therapy; no complementary or
alternative therapy (e.g., St. John's Wort, PC-SPES, or any other herbal remedies
taken for the purpose of treating prostate cancer) may be given during protocol

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to perifosine

- Androgen deprivation given for reasons other than neoadjuvant or adjuvant therapy

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study because of possible pharmacokinetic interactions with perifosine;
appropriate studies will be undertaken in patients receiving combination
anti-retroviral therapy when indicated

- No prior malignancy is allowed except for the following: adequately treated basal
cell or squamous cell skin cancer, in situ carcinoma of any site, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for 5 years

Type of Study:


Study Design:

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

Outcome Measure:

PSA response

Outcome Time Frame:

Up to 6 years

Safety Issue:


Principal Investigator

Primo Lara

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



City of Hope Duarte, California  91010