Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT00113347 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2012-02-27
Summary
The goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer.
Conditions
Interventions
- DRUG
-
Erlotinib
Beginning on Day 2 of treatment, 100, 125, or 150 mg by mouth once a day every day while on treatment, except on days docetaxel is received.
- DRUG
-
15 mg/m\^2 or 20 mg/m\^2 by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment.
- RADIATION
-
Radiation Therapy
Radiation therapy to head/neck beginning on day 1 of treatment once daily 5 times per week (Monday through Friday), delivered in 40 fractions.
Sponsors & Collaborators
-
Aventis Pharmaceuticals
collaborator INDUSTRY -
Genentech, Inc.
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Bonnie S. Glisson, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-04-30
- Primary Completion
- 2011-04-30
- Completion
- 2011-04-30
Countries
- United States
Study Locations
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