Erlotinib, Docetaxel, and Radiation Therapy in Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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 of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with docetaxel and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well erlotinib given together with docetaxel and radiation therapy works in treating patients with stage III or stage IV squamous cell carcinoma of the head and neck.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Erlotinib Hydrochloride

Criteria

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