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Completed

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

ClinicalTrials.gov ID NCT00060437
Sponsor National Cancer Institute (NCI)
Information provided by National Cancer Institute (NCI)
Last Update Posted 2013-06-19
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Study Overview

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.

Detailed Description

OBJECTIVES:

  • 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.

OUTLINE:

  • 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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Official Title
A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer
Conditions
Prostate Cancer
Intervention / Treatment
  • Drug: perifosine
  • Drug: perifosine
Other Study ID Numbers
  • CDR0000301951
  • NCI-03-C-0157
    NCI-03-C-0157
  • NCI-5970
    NCI-5970
Obsolete Identifiers
  • NCT00058708
Study Start
2003-10
Study Completion (Actual)
2004-04
Study Type
Interventional
Phase
Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • 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 less than 1.0 mg/dL or upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN

Renal

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

Cardiovascular

  • 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

Ophthalmic

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • 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
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Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Masking : None (Open Label)

Arms and Interventions

Intervention/Treatment
Intervention/Treatment
Drug: perifosine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
National Cancer Institute (NCI)
Investigators
  • Study Chair:Edwin M. Posadas, MD,National Cancer Institute (NCI)

Publications

Study Results

These publications are provided voluntarily by the person who enters information about the study and are about the study results.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2003-05-06
First Submitted that Met QC Criteria
2003-05-06
First Posted (Estimated)
2003-05-07
Study Record Updates
Last Update Submitted that met QC Criteria
2013-06-18
Last Update Posted (Estimated)
2013-06-19
Last Verified
2004-04

More Information

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Keywords Provided by National Cancer Institute (NCI)
Additional Relevant MeSH Terms