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Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00040807
Study type Interventional
Source Eastern Cooperative Oncology Group
Contact
Status Completed
Phase Phase 2
Start date November 19, 2002
Completion date May 1, 2009
View Details
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