Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
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.
Head and Neck Cancer
Drug: irinotecan hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma|
|Study Start Date:||October 2002|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
- 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.