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Perifosine in Treating Patients With Recurrent Prostate Cancer
This study has been completed.

First Received on April 7, 2003.   Last Updated on October 4, 2010   History of Changes
Sponsor: California Cancer Consortium
Collaborator: National Cancer Institute (NCI)
Information provided by: California Cancer Consortium
ClinicalTrials.gov Identifier: NCT00058214
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: perifosine
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Perifosine (IND 58, 156; NSC# 639966) In Biochemically Recurrent, Hormone Sensitive Prostate Cancer

Resource links provided by NLM:


Further study details as provided by California Cancer Consortium:

Study Start Date: March 2003
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058214

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
California Cancer Consortium
Investigators
Study Chair: Primo N. Lara, MD University of California, Davis
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00058214     History of Changes
Other Study ID Numbers: CDR0000287195, CCC-PHII-44, CHNMC-PHII-44-02166, NCI-5978
Study First Received: April 7, 2003
Last Updated: October 4, 2010
Health Authority: United States: Federal Government

Keywords provided by California Cancer Consortium:
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012