Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
- Registration Number
- NCT00062387
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I perifosine 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.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Central Illinois Hematology Oncology Center
🇺🇸Springfield, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
LaGrange Memorial Hospital
🇺🇸LaGrange, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
Evanston Northwestern Health Care - Evanston Hospital
🇺🇸Evanston, Illinois, United States
Oncology Care Associates, P.L.L.C.
🇺🇸Saint Joseph, Michigan, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States