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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Aventis Pharmaceuticals Genentech |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00113347 |
Patients will receive 6 weeks of treatment. On days 1, 8, 15, and 22, they will receive 15 mg/m2 or 20 mg/m2 docetaxel. On all other days (i.e., days on which the patient does not receive docetaxel), the patient will take 100, 125, or 150 mg of erlotinib.
Patients will also receive radiation therapy beginning on day 1 of treatment. Treatment will be delivered in 40 fractions. During weeks 1-3, patients will receive XRT once daily 5 times per week (Monday through Friday). The patient will not receive treatment on weekends. The target dose depends upon the target volume. During weeks 4-6, patients will receive their treatment in fractions with a minimum of 6 hours between radiation treatments.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: Erlotinib Drug: Docetaxel Radiation: Radiation Therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck |
Estimated Enrollment: | 24 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | April 2010 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Erlotinib + Docetaxel: Experimental
Erlotinib and Docetaxel with Concomitant Boost Radiation to Head/Neck
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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: 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.
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Bonnie S. Glisson, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Bonnie Glisson, MD/Professor ) |
Study ID Numbers: | 2003-1049 |
Study First Received: | June 7, 2005 |
Last Updated: | May 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00113347 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Head and Neck Cancer Squamous Cell Carcinoma Erlotinib Docetaxel |
Radiation Radiotherapy Concomitant Boost Radiation |
Erlotinib Docetaxel Head and Neck Neoplasms Epidermoid Carcinoma Carcinoma, Squamous Cell of Head and Neck Neoplasms, Squamous Cell |
Squamous Cell Carcinoma Carcinoma, Squamous Cell Protein Kinase Inhibitors Neoplasms, Glandular and Epithelial Carcinoma |
Erlotinib Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Docetaxel Neoplasms Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |