Erlotinib, Docetaxel, and Radiation Therapy in Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00720304
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 43
DISEASE CHARACTERISTICS:<br><br> - Histologically or cytologically confirmed locally advanced squamous cell carcinoma<br> of the head and neck<br><br> - Stage III or IV disease<br><br> - No distant metastatic disease<br><br> - Measurable disease (according to RECIST)<br><br> - No salivary gland and paranasal sinus squamous cell carcinoma<br><br> - No known brain metastases or direct cerebral invasion by tumor<br><br> - Intracranial extension (without cerebral involvement) may be allowed<br><br>PATIENT CHARACTERISTICS:<br><br> - ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%<br><br> - Life expectancy > 12 weeks<br><br> - ANC = 1,500/mm^3<br><br> - Platelet count = 100,000/mm^3<br><br> - Hemoglobin =10 g/dL<br><br> - Total bilirubin normal<br><br> - Alkaline phosphatase AND AST and ALT meeting the following criteria:<br><br> - Alkaline phosphatase normal AND AST and ALT = 5 times upper limit of normal<br> (ULN)<br><br> - Alkaline phosphatase = 2.5 times ULN AND AST and ALT = 2.5 times ULN<br><br> - Alkaline phosphatase = 5 times ULN AND AST and ALT normal<br><br> - Creatinine normal OR creatinine clearance = 60 mL/min<br><br> - No clinically significant heart disease including any of the following:<br><br> - NYHA class III or IV heart disease<br><br> - Significant arrhythmias requiring medication<br><br> - Symptomatic coronary artery disease<br><br> - Myocardial infarction within the previous six months<br><br> - Second- or third-degree heart block or bundle-branch block<br><br> - Not pregnant or nursing<br><br> - Negative pregnancy test<br><br> - Fertile patients must use effective contraception during and for at least 3 months<br> after completion of study therapy<br><br> - No history of allergic reactions attributed to compounds of similar chemical or<br> biologic composition to erlotinib hydrochloride or docetaxel, including other drugs<br> formulated with polysorbate 80<br><br> - No pre-existing peripheral neuropathy = grade 2<br><br> - No uncontrolled concurrent illness including, but not limited to, any of the<br> following:<br><br> - Ongoing or active infection<br><br> - Symptomatic congestive heart failure<br><br> - Unstable angina pectoris<br><br> - Cardiac arrhythmia<br><br> - Psychiatric illness/social situations that would preclude compliance with study<br> requirements<br><br> - No HIV positivity<br><br> - No other prior malignancy except for any of the following:<br><br> - Squamous cell or basal cell carcinoma of the skin<br><br> - Carcinoma in situ of the cervix<br><br> - Cancer that was treated more than 5 years ago and the patient has remained<br> disease-free<br><br> - Not poorly compliant<br><br>PRIOR CONCURRENT THERAPY:<br><br> - No prior chemotherapy, radiotherapy, or investigational antitumor drug<br><br> - No other concurrent investigational agents
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent of Participants With Disease-Free Survival (DFS) at 3 Years;Time to Progression (TTP)
- Secondary Outcome Measures
Name Time Method Response Rate (Complete Response, Partial Response, Stable Disease, and Disease Progression);Overall Survival (OS);Number of Participants With Acute Grade III/IV Treatment-related Toxicities;Percent of Participants With Local Failure-free Survival;Percent of Participants With Regional Failure-free Survival;Percent of Participants With Locoregional Failure-free Survival;Percent of Participants With Distant Metastasis-free Survival