Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00040807
- Lead Sponsor
- Eastern Cooperative Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Penrose Cancer Center
🇺🇸Colorado Springs, Colorado, 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
MBCCOP-Our Lady of Mercy Cancer Center
🇺🇸Bronx, New York, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Medical Center of Aurora - South Campus
🇺🇸Aurora, Colorado, United States
Stanford Cancer Center at Stanford University Medical Center
🇺🇸Stanford, California, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers - Denver Rose
🇺🇸Denver, Colorado, United States
St. Mary-Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Rocky Mountain Cancer Centers - Thornton
🇺🇸Thornton, Colorado, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital
🇺🇸Longmont, Colorado, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States