Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Perifosine in Treating Patients With Recurrent Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Over 18	NCI	CCC-PHII-44 CHNMC-PHII-44-02166, NCI-5978, 5978, NCT00058214

Objectives

1. Determine the prostate-specific antigen (PSA) response to perifosine in patients with hormone-sensitive prostate cancer who have a biochemical recurrence after prior local curative therapy.
2. Compare the 6-month increase in PSA levels with baseline in patients treated with this drug.
3. Determine the PSA doubling time and time to PSA progression in patients treated with this drug.
4. Determine the qualitative and quantitative toxic effects of this drug in these patients.
5. Identify potential molecular markers predictive of decreased PSA doubling time and, possibly, PSA response in patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed adenocarcinoma of the prostate



• Biochemical recurrence
  • Rising prostate-specific antigen (PSA) of at least 2.0 ng/mL following a nadir after local curative therapy (radical prostatectomy and/or pelvic radiotherapy)
    • Rising PSA must be confirmed by 2 consecutive increases measured at least 2 weeks apart



• No evidence of local or distant relapse by physical exam or radiography



• No clinical or radiographic evidence of metastatic disease by all of the following:
  • CT scan or MRI of the pelvis
  • Bone scan
  • Posterior, anterior, and lateral x-ray

Prior/Concurrent Therapy:

Biologic therapy

• At least 6 months since prior vaccine therapy
• No concurrent biological response modifiers

Chemotherapy

• No prior cytotoxic chemotherapy
• No other concurrent chemotherapy

Endocrine therapy

• Prior adjuvant or neoadjuvant hormonal therapy allowed provided treatment duration was no longer than 9 months*
• At least 1 year since prior neoadjuvant or adjuvant androgen deprivation therapy*
• No concurrent corticosteroids
• No concurrent hormonal therapy

 [Note: *No rising PSA at the time therapy was discontinued]

Radiotherapy

• See Disease Characteristics
• No concurrent radiotherapy

Surgery

• See Disease Characteristics

Other

• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies (investigational or commercial)
• No concurrent complementary or alternative therapy (e.g., Hypericum perforatum [St. John's Wort], PC-SPES, or any other herbal remedy for the treatment of prostate cancer)
• No concurrent combination antiretroviral therapy for HIV-positive patients

Patient Characteristics:

Age

• Over 18

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• AST and ALT no greater than 2.5 times upper limit of normal

Renal

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Fertile patients must use effective contraception
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to perifosine
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or adequately treated stage I or II cancer currently in complete remission
• No ongoing or active infection
• No other concurrent uncontrolled illness
• No psychiatric illness or social situation that would preclude study compliance

Expected Enrollment

A total of 21-41 patients will be accrued for this study.

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.

Chee KG, Longmate J, Quinn DI, et al.: The AKT inhibitor perifosine in biochemically recurrent prostate cancer: a phase II California/Pittsburgh cancer consortium trial. Clin Genitourin Cancer 5 (7): 433-7, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

California Cancer Consortium

Primo Lara, MD, Protocol chair		Ph: 916-734-3771

Registry Information
Official Title		A Phase II Trial Of Perifosine (IND 58, 156; NSC# 639966) In Biochemically Recurrent, Hormone Sensitive Prostate Cancer
Trial Start Date		2003-03-13
Trial Completion Date		2009-01-20
Registered in ClinicalTrials.gov		NCT00058214
Date Submitted to PDQ		2003-02-25
Information Last Verified		2004-12-06
NCI Grant/Contract Number		P30-CA33572

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