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

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00062387
First received: June 5, 2003
Last updated: May 31, 2013
Last verified: October 2004

June 5, 2003
May 31, 2013
May 2003
January 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00062387 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
Drug: perifosine
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.
Intervention: Drug: perifosine
Argiris A, Cohen E, Karrison T, Esparaz B, Mauer A, Ansari R, Wong S, Lu Y, Pins M, Dancey J, Vokes E. A phase II trial of perifosine, an oral alkylphospholipid, in recurrent or metastatic head and neck cancer. Cancer Biol Ther. 2006 Jul;5(7):766-70. Epub 2006 Jul 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
46
January 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00062387
NCI-2012-02538, UCCRC-12198A, NCI-5938, CDR0000304740
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Athanassios Argiris, MD Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
October 2004

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