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)
University of Alabama at Birmingham Comprehensive Cancer Center
πΊπΈBirmingham, Alabama, United States
Stanford Cancer Center at Stanford University Medical Center
πΊπΈStanford, California, United States
Medical Center of Aurora - South Campus
πΊπΈAurora, Colorado, United States
Boulder Community Hospital
πΊπΈBoulder, Colorado, United States
Penrose Cancer Center
πΊπΈColorado Springs, Colorado, United States
Porter Adventist Hospital
πΊπΈDenver, Colorado, United States
St. Joseph Hospital
πΊπΈDenver, Colorado, United States
Presbyterian - St. Luke's Medical Center
πΊπΈDenver, Colorado, United States
Rocky Mountain Cancer Centers - Denver Rose
πΊπΈDenver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
πΊπΈDenver, Colorado, United States
Scroll for more (33 remaining)University of Alabama at Birmingham Comprehensive Cancer CenterπΊπΈBirmingham, Alabama, United States