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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
Aventis Pharmaceuticals Genentech |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00113347 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: Erlotinib Drug: Docetaxel Radiation: Radiation Therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck |
| Enrollment: | 10 |
| Study Start Date: | April 2005 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Erlotinib + Docetaxel
Erlotinib 100, 125, or 150 mg orally daily except days receive Docetaxel 15 mg/m^2 or 20 mg/m^2 intravenously with Concomitant Boost Radiation to Head/Neck
|
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.
Other Names:
Drug: Docetaxel
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.
Other Name: Taxotere
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.
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Bonnie S. Glisson, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Bonnie Glisson, MD/Professor, U.T. M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00113347 History of Changes |
| Other Study ID Numbers: | 2003-1049 |
| Study First Received: | June 7, 2005 |
| Last Updated: | April 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Head and Neck Cancer Squamous Cell Carcinoma Erlotinib Docetaxel |
Radiation Radiotherapy Concomitant Boost Radiation |
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
Docetaxel Erlotinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |