Status:
COMPLETED
Erlotinib, Docetaxel, and Radiation Therapy in Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth...
Detailed Description
OBJECTIVES: Primary * Determine the time to progression in patients with locally advanced squamous cell carcinoma of the head and neck treated with erlotinib hydrochloride in combination with doceta...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced squamous cell carcinoma of the head and neck
- Stage III or IV disease
- No distant metastatic disease
- Measurable disease (according to RECIST)
- No salivary gland and paranasal sinus squamous cell carcinoma
- No known brain metastases or direct cerebral invasion by tumor
- Intracranial extension (without cerebral involvement) may be allowed
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy \> 12 weeks
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥10 g/dL
- Total bilirubin normal
- Alkaline phosphatase AND AST and ALT meeting the following criteria:
- Alkaline phosphatase normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN AND AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 5 times ULN AND AST and ALT normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- No clinically significant heart disease including any of the following:
- NYHA class III or IV heart disease
- Significant arrhythmias requiring medication
- Symptomatic coronary artery disease
- Myocardial infarction within the previous six months
- Second- or third-degree heart block or bundle-branch block
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after completion of study therapy
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride or docetaxel, including other drugs formulated with polysorbate 80
- No pre-existing peripheral neuropathy ≥ grade 2
- No uncontrolled concurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would preclude compliance with study requirements
- No HIV positivity
- No other prior malignancy except for any of the following:
- Squamous cell or basal cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Cancer that was treated more than 5 years ago and the patient has remained disease-free
- Not poorly compliant
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or investigational antitumor drug
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
November 19 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2015
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00720304
Start Date
November 19 2007
End Date
November 13 2015
Last Update
August 22 2024
Active Locations (1)
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1
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065