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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Aventis Pharmaceuticals Genentech |
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 |
MedlinePlus related topics: | Cancer Head and Neck Cancer |
ChemIDplus related topics: | Docetaxel Erlotinib Erlotinib hydrochloride |
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 Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: 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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Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram:
Patients with a history of non-melanoma skin cancer, or other previous malignancies treated 5 years or more prior to the current tumor from which the patient has remained continually disease-free, are eligible.
Exclusion Criteria:
Contact: Bonnie S. Glisson, MD | 713-792-6363 |
United States, Texas | |||||
MD Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Contact: Bonnie Glisson, MD 713-792-6363 bglisson@mdanderson.org | |||||
Contact: Louise Christmas, RN 713-745-6760 lchristmas@mdanderson.org | |||||
Principal Investigator: Bonnie S. Glisson, MD | |||||
Sub-Investigator: Adam Garden, MD |
M.D. Anderson Cancer Center |
Aventis Pharmaceuticals |
Genentech |
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 |
First Received: | June 7, 2005 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00113347 |
Health Authority: | United States: Food and Drug Administration |
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