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

Plain-language summary

This study evaluates Erlotinib, Docetaxel, and radiation therapy in patients with locally advanced (Stage III or IV) head and neck squamous cell carcinoma. It included patients with measurable disease and no distant metastases. It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Case Comprehensive Cancer Center

Intervention

docetaxel, erlotinib hydrochloride, fluorescence in situ hybridization, polymerase chain reaction, immunoenzyme technique, immunohistochemistry staining method, laboratory biomarker analysis, pharmacological study, therapeutic conventional surgery, intensity-modulated radiation therapy, radiation therapy

Start date

11/19/2007

Estimated completion

11/13/2015

Countries

United States

Related genes

Locations

• Cleveland, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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