Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma
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.
Interventional
Primary Purpose: Treatment
Athanassios Argiris, MD
Study Chair
Robert H. Lurie Cancer Center
United States: Federal Government
CDR0000069408
NCT00040807
October 2002
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Evanston | Evanston, Illinois 60201 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
Albert Einstein Clinical Cancer Center | Bronx, New York 10461 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Stanford Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
MBCCOP-Our Lady of Mercy Cancer Center | Bronx, New York 10466 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
St. Mary-Corwin Regional Medical Center | Pueblo, Colorado 81004 |
Penrose Cancer Center | Colorado Springs, Colorado 80933 |
Medical Center of Aurora - South Campus | Aurora, Colorado 80012-0000 |
Rocky Mountain Cancer Centers - Denver Rose | Denver, Colorado 80220 |
Rocky Mountain Cancer Centers - Thornton | Thornton, Colorado 80229 |