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Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Clinical research trials and Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer. Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer  Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
For Condition: Head and Neck Cancer
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AthanassiosArgiris, Study Chair, Robert H. Lurie Cancer Center
LaGrange Memorial Hospital *Recruiting*
LaGrange, Illinois, 60525
United States
Recruiting James Hannigan 708-579-3418
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Stuart Wong 414-805-4603
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Everett Vokes 773-702-9306
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting David Sciortino 219-484-8830
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting David Taber 800-284-7370
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Ellen Gaynor 708-327-3101
Oncology/Hematology Associates of Central Illinois, P.C. *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting James Knost 309-672-5681
Decatur Memorial Hospital Cancer Care Institute *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6603
Ingalls Memorial Hospital *Recruiting*
Harvey, Illinois, 60426
United States
Recruiting Mark Kozloff 708-333-2300
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201-1781
United States
Recruiting Bruce Brockstein 847-570-1489
Oncology Care Associates, P.L.L.C. *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 616-985-0029
Central Illinois Hematology Oncology Center *Recruiting*
Springfield, Illinois, 62701
United States
Recruiting Edem Agamah 217-525-2500
Additional Information:
Study ID Numbers: CDR0000304740; UCCRC-12198A,NCI-5938
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062387
Other Head And Neck Cancer Studies:
1. Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck
2. Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
3. Motexafin Gadolinium with Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
4. Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
5. Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other Illinois Clinical Trials
Other Evanston Clinical Trials
Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
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