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