NCT00040807

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	irinotecan hydrochloride

Timeline

• Start date: 2002-11-19
• Primary completion: 2005-04-01
• Completion: 2009-05-01
• First posted: 2003-01-27
• Last updated: 2023-06-18

Locations

43 sites across 1 country: United States

Regulatory

• FDA-regulated drug study