Evre III veya IV Baş-Boyun Yassı Hücreli Karsinomunda Erlotinib, Dosetaksel ve Radyoterapi

Sade dilde özet

Bu çalışma, lokal ileri (Evre III veya IV) baş-boyun yassı hücreli karsinomu (head and neck squamous cell carcinoma) hastalarında Erlotinib, Dosetaksel ve radyoterapi tedavisini inceliyor. Uzak metastazı olmayan, ölçülebilir hastalığı olan hastalar dahil edilmiştir. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Case Comprehensive Cancer Center

Müdahale

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

Başlangıç

19.11.2007

Tahmini bitiş

13.11.2015

Ülkeler

United States

İlgili genler

Merkezler

• Cleveland, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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