Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
- Registration Number
- NCT00024089
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent and/or metastatic head and neck cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells by blocking an enzyme necessary for cell growth.
- Detailed Description
OBJECTIVES:
I. Determine the disease control rate, in terms of complete response, partial response, and stable disease for at least 4 months, in patients with recurrent and/or metastatic squamous cell cancer of the head and neck treated with gefitinib.
II. Determine the effect of this drug on epidermal growth factor receptor phosphorylation and expression of selected genes in these patients.
III. Determine the toxic effects of this drug in these patients.
OUTLINE: Patients are stratified as delineated in the Disease Characteristics.
Patients receive oral gefitinib daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I gefitinib Patients receive oral gefitinib daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Disease control rate
- Secondary Outcome Measures
Name Time Method Biologic parameters Toxicity Response
Trial Locations
- Locations (1)
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States