Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Status and phase
Conditions
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Study type
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Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
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Unidimensionally measurable disease
- At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by CT scan
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
46 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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