Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
NCT00083057 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2012-03-15
Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving gefitinib and paclitaxel together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib and paclitaxel when given together with radiation therapy in treating patients with advanced or recurrent squamous cell carcinoma (cancer) of the head and neck.
Conditions
Interventions
- DRUG
-
gefitinib
- DRUG
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
National Institutes of Health Clinical Center (CC)
lead NIH
Principal Investigators
-
Carter Van Waes, MD, PhD · National Institute on Deafness and Other Communication Disorders (NIDCD)
-
John C. Morris, MD · NCI - Metabolism Branch;MET
Study Design
- Purpose
- TREATMENT
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-05-31
- Primary Completion
- 2010-10-31
- Completion
- 2010-11-30
Countries
- United States
Study Locations
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