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Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00060437
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have prostate cancer that no longer responds to androgen ablation therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: perifosine Phase 2

Detailed Description:


  • Determine the 4-month progression-free survival rate, as measured by prostate-specific antigen and clinical criteria, in patients with metastatic androgen-independent prostate cancer treated with perifosine.
  • Determine the side-effect profile of this drug in these patients.
  • Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.


  • Course 1: Patients receive oral perifosine twice on day 1 and once daily on days 2-21.
  • All subsequent courses: Patients receive oral perifosine once daily on days 1-21.

In all courses, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within approximately 1.5 years.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer
Study Start Date : October 2003
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria:

    • Metastatic
    • Androgen-independent
    • Progressive disease while continuing to receive hormonal ablation (e.g., luteinizing hormone-releasing hormone [LHRH] agonist)
  • Progression documented by at least 1 of the following parameters:

    • Two consecutively rising prostate-specific antigen levels, at least 1 week apart, with at least 1 measurement that is 50% above the nadir reached after the last treatment regimen (as long as the last measurement is at least 5 ng/mL)
    • At least 1 new metastatic lesion on technetium Tc 99m bone scintigraphy
    • Progression of soft-tissue metastases as measured by appropriate modalities (i.e., imaging or palpation) and demonstrated by at least 1 of the following:

      • Development of new area of malignant disease (measurable or nonmeasurable)
      • At least a 20% increase in the sum of the longest diameters (LD) of target lesions from the smallest sum of LD recorded since the treatment started or the appearance of 1 or more new lesions
  • Patients who have not undergone surgical castration must have a testosterone level less than 50 ng/mL and continue on their LHRH agonist during study treatment
  • No known brain metastases



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months


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


  • Bilirubin less than 1.0 mg/dL or upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • No myocardial infarction within the past 6 months
  • No unstable or newly diagnosed angina pectoris
  • No New York Heart Association class II-IV congestive heart failure


  • No pre-existing retinal disease
  • No pathologic baseline electrooculogram


  • Fertile patients must use effective barrier contraception
  • Able to ingest oral medication
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine (e.g., miltefosine or edelfosine)
  • No ongoing or active infection
  • No other concurrent uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance
  • No other active malignancies within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder


Biologic therapy

  • Not specified


  • No more than 1 prior chemotherapy regimen
  • More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • See Disease Characteristics
  • More than 4 weeks since prior flutamide
  • More than 6 weeks since prior bicalutamide or nilutamide


  • At least 6 weeks since prior bone-seeking radioisotopes
  • Recovered from prior radiotherapy


  • See Disease Characteristics
  • Recovered from prior surgery


  • Recovered from any acute toxicity related to prior therapy
  • More than 3 months since prior UCN-01
  • More than 3 months since prior suramin
  • No concurrent commercial or other investigational agents or therapies intended to treat the malignancy
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00060437

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Edwin M. Posadas, MD National Cancer Institute (NCI)
Publications of Results:
Posadas EM, Trout A, Senderowicz AM, et al.: A phase II trial of oral perifosine in patients with metastatic androgen-independent prostate cancer (AIPC). [Abstract] SUO/NCI Urologic Oncology Meeting, December 5-6, 2003, Bethesda, MD. A-54, 38, 2003.

Layout table for additonal information Identifier: NCT00060437    
Obsolete Identifiers: NCT00058708
Other Study ID Numbers: CDR0000301951
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: April 2004
Keywords provided by National Cancer Institute (NCI):
stage IV prostate cancer
recurrent prostate cancer
adenocarcinoma of the prostate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases