Spots Global Cancer Trial Database for Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
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Trial Identification
Brief Title: Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Official Title: Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma
Study ID: NCT00040807
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of irinotecan and docetaxel in treating patients who have metastatic or locally recurrent head and neck cancer.
Detailed Description: OBJECTIVES: * Determine the response rate in patients with metastatic or locally recurrent head and neck cancer treated with irinotecan and docetaxel. * Determine the progression-free and overall survival of patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. * Correlate angiogenesis markers and cyclooxygenase-2 expression with response and survival in patients treated with this regimen. * Correlate UGT1A1 genotype with the toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (no prior chemotherapy for locally recurrent or metastatic disease or more than 6 months since prior chemotherapy as primary therapy vs 1 prior chemotherapy regimen for locally recurrent or metastatic disease or less than 6 months since prior chemotherapy as primary therapy). Patients receive docetaxel IV over 60 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 32-72 patients (16-36 per stratum) will be accrued for this study within 6-14 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, United States
Medical Center of Aurora - South Campus, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
Rocky Mountain Cancer Centers - Denver Rose, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States
St. Mary-Corwin Regional Medical Center, Pueblo, Colorado, United States
Rocky Mountain Cancer Centers - Thornton, Thornton, Colorado, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
CCOP - Wichita, Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Tufts - New England Medical Center, Boston, Massachusetts, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Albert Einstein Clinical Cancer Center, Bronx, New York, United States
MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
CCOP - Oklahoma, Tulsa, Oklahoma, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Contact Details
Name: Athanassios Argiris, MD
Affiliation: Robert H. Lurie Cancer Center
Role: STUDY_CHAIR
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