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TERMINATEDPHASE2

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

NCT00058214•National Cancer Institute (NCI)

Summary

Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent prostate cancer. Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die

Detailed Description

PRIMARY OBJECTIVES: 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 population. 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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate
•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
+7 more criteria

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 treatment
•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

Locations (1)

UC Davis Cancer Center

Sacramento, California, United States

Key Dates

Start Date

March 1, 2003

Primary Completion Date

January 1, 2009

Completion Date

January 1, 2009

Last Updated

February 23, 2015

Enrollment

ACTUAL participants

Conditions

Adenocarcinoma of the ProstateRecurrent Prostate CancerStage IIB Prostate CancerStage III Prostate CancerStage IV Prostate Cancer

Interventions

perifosine

DRUG

laboratory biomarker analysis

OTHER

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Perifosine in Treating Patients With Recurrent Prostate Cancer

Inclusion Criteria

Exclusion Criteria

SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma

Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors

Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery

Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)

Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)

Treatment of Locally Recurrent Prostate Cancer