Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
|ClinicalTrials.gov Identifier: NCT00113347|
Recruitment Status : Completed
First Posted : June 8, 2005
Last Update Posted : February 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Erlotinib Drug: Docetaxel Radiation: Radiation Therapy||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date :||April 2005|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
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
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: TaxotereRadiation: 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.
- Maximum tolerated dose (MTD) of erlotinib and docetaxel during concomitant boost radiation [ Time Frame: 6 weeks of treatment, followed ]MTD defined as highest dose level in which 6 patients have been treated with less than or equal to 2 instances of Dose-limiting toxicity (DLT) from 2 sources: 1) Out-of-field toxicity from unirradiated sites secondary to systemic therapy(erlotinib and docetaxel); 2) In-field toxicity from irradiated sites secondary to combined treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113347
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bonnie S. Glisson, MD||M.D. Anderson Cancer Center|