Clinical trial NCT00062387: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-06-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital Cancer Care Institute
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Health Care - Evanston Hospital
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: LaGrange
country: United States
facility: LaGrange Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center at Loyola University Medical Center
state: Illinois
city: Peoria
country: United States
facility: Oncology/Hematology Associates of Central Illinois, P.C.
state: Illinois
city: Springfield
country: United States
facility: Central Illinois Hematology Oncology Center
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology, Incorporated
state: Indiana
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Saint Joseph
country: United States
facility: Oncology Care Associates, P.L.L.C.
state: Michigan
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Athanassios Argiris, MD
role: STUDY_CHAIR
References:
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.