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Perifosine in Treating Patients With Recurrent Prostate Cancer
This study has been completed.
Study NCT00058214   Information provided by National Cancer Institute (NCI)
First Received: April 7, 2003   Last Updated: February 7, 2009   History of Changes

April 7, 2003
February 7, 2009
March 2003
January 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00058214 on ClinicalTrials.gov Archive Site
 
 
 
Perifosine in Treating Patients With Recurrent Prostate Cancer
A Phase II Trial Of Perifosine (IND 58, 156; NSC# 639966) In Biochemically Recurrent, Hormone Sensitive Prostate Cancer

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 recurrent prostate cancer.

OBJECTIVES:

  • 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.
  • Compare the 6-month increase in PSA levels with baseline in patients treated with this drug.
  • Determine the PSA doubling time and time to PSA progression in patients treated with this drug.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Identify potential molecular markers predictive of decreased PSA doubling time and, possibly, PSA response in patients treated with this drug.

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.

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

Phase II
Interventional
Treatment, Open Label
Prostate Cancer
Drug: perifosine
 
Chee KG, Longmate J, Quinn DI, Chatta G, Pinski J, Twardowski P, Pan CX, Cambio A, Evans CP, Gandara DR, Lara PN Jr. The AKT inhibitor perifosine in biochemically recurrent prostate cancer: a phase II California/Pittsburgh cancer consortium trial. Clin Genitourin Cancer. 2007 Dec;5(7):433-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
January 2009   (final data collection date for primary outcome measure)

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

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

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

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

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00058214
 
CDR0000287195, CCC-PHII-44, CHNMC-PHII-44-02166, NCI-5978
California Cancer Consortium
National Cancer Institute (NCI)
Study Chair: Primo N. Lara, MD University of California, Davis
National Cancer Institute (NCI)
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP