A Phase II Study Of Perifosine In Patients With Recurrent Or Metastatic Head And Neck Cancer
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Phase II Study Of Perifosine In Patients With Recurrent Or Metastatic Head And Neck Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Athanassios Argiris, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02538
NCT ID:
NCT00062387
Start Date:
May 2003
Completion Date:
January 2007
Related Keywords:
- Head and Neck Cancer
- 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
- Head and Neck Neoplasms
Name | Location |
|---|---|
| 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 |
