RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent or metastatic head and neck cancer.

Condition	Treatment or Intervention	Phase
Head and Neck Cancer	Drug: perifosine  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the antitumor activity of perifosine in patients with recurrent or metastatic squamous cell head and neck cancer.
• Determine the time to progression and overall survival of patients treated with this drug.
• Determine the toxicity of this drug in these patients.
• Determine the pharmacodynamics of this drug in these patients.
• Assess the usefulness of biomarkers in predicting response and other outcome parameters in patients treated with this drug.
• 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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)

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy

Surgery

• Not specified

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

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

Study chairs or principal investigators

Athanassios Argiris, MD,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000304740; UCCRC-12198A; NCI-5938
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  June 5, 2003
ClinicalTrials.gov Identifier:  NCT00062387
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08