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

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
perifosine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage IV salivary gland cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Cancer Research Center
  • Decatur Memorial Hospital Cancer Care Institute
  • Evanston Northwestern Health Care - Evanston Hospital
  • Ingalls Memorial Hospital
  • LaGrange Memorial Hospital
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
  • Oncology/Hematology Associates of Central Illinois, P.C.
  • Central Illinois Hematology Oncology Center
  • Fort Wayne Medical Oncology and Hematology, Incorporated
  • CCOP - Northern Indiana CR Consortium
  • Oncology Care Associates, P.L.L.C.
  • Medical College of Wisconsin Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 5, 2003
Last Updated
May 31, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00062387
Brief Title
Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Official Title
A Phase II Study Of Perifosine In Patients With Recurrent Or Metastatic Head And Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2004
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
May 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage IV salivary gland cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
perifosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanassios Argiris, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston Northwestern Health Care - Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
LaGrange Memorial Hospital
City
LaGrange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Incorporated
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Oncology Care Associates, P.L.L.C.
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16760642
Citation
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. doi: 10.4161/cbt.5.7.2874. Epub 2006 Jul 2.
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Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

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