A Phase II Study Of Perifosine In Patients With Recurrent Or Metastatic Head And Neck Cancer
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
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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Athanassios Argiris, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Cardinal Bernardin Cancer Center at Loyola University Medical Center||Maywood, Illinois 60153-5500|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|Fort Wayne Medical Oncology and Hematology, Incorporated||Fort Wayne, Indiana 46885-5099|
|Evanston Northwestern Health Care - Evanston Hospital||Evanston, Illinois 60201|
|Oncology/Hematology Associates of Central Illinois, P.C.||Peoria, Illinois 61602|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|Oncology Care Associates, P.L.L.C.||Saint Joseph, Michigan 49085|
|LaGrange Memorial Hospital||LaGrange, Illinois 60525|