Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

May 31, 2013 updated by: National Cancer Institute (NCI)

A Phase II Study Of Perifosine In Patients With Recurrent Or Metastatic Head And Neck Cancer

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. Determine the antitumor activity of perifosine in patients with recurrent or metastatic squamous cell head and neck cancer.

II. Determine the time to progression and overall survival of patients treated with this drug.

III. Determine the toxicity of this drug in these patients. IV. Determine the pharmacodynamics of this drug in these patients. V. Assess the usefulness of biomarkers in predicting response and other outcome parameters in patients treated with this drug.

VI. Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral perifosine 4 times daily on days 1 and 2 and once daily on days 3-28 during course 1. Patients receive oral perifosine once daily on days 1-28 for all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, weekly during the first month, every 28 days after the first month, and then at study withdrawal.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 2 years.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Evanston, Illinois, United States, 60201-1781
        • Evanston Northwestern Health Care - Evanston Hospital
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • LaGrange, Illinois, United States, 60525
        • LaGrange Memorial Hospital
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Peoria, Illinois, United States, 61602
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Springfield, Illinois, United States, 62701
        • Central Illinois Hematology Oncology Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46885-5099
        • Fort Wayne Medical Oncology and Hematology, Incorporated
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Oncology Care Associates, P.L.L.C.
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell cancer of the head and neck

    • Metastatic or recurrent disease
    • Not amenable to surgery or radiotherapy

  • Unidimensionally measurable disease

    • At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by CT scan
  • 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 normal
  • AST/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

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to perifosine
  • No ongoing or active infection
  • No other concurrent uncontrolled illness
  • No psychiatric illness or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No more than 1 prior biologic/targeted regimen for recurrent or metastatic disease

Chemotherapy

  • No more than 1 prior adjuvant or neoadjuvant chemotherapy and/or concurrent chemoradiotherapy regimen
  • No more than 1 prior chemotherapy regimen for recurrent or metastatic disease
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Other

  • Recovered from prior therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive oral perifosine 4 times daily on days 1 and 2 and once daily on days 3-28 during course 1. Patients receive oral perifosine once daily on days 1-28 for all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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: Athanassios Argiris, MD, Robert H. Lurie Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

June 5, 2003

First Submitted That Met QC Criteria

June 5, 2003

First Posted (Estimate)

June 6, 2003

Study Record Updates

Last Update Posted (Estimate)

June 3, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

October 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02538
  • UCCRC-12198A
  • NCI-5938
  • CDR0000304740 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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