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Phase I/II Study of Secondary Primary Tumor Prevention With Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva™ ), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Early Stage (Stage I/II) Squamous Cell Carcinoma of Head and Neck


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Phase I/II Study of Secondary Primary Tumor Prevention With Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva™ ), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Early Stage (Stage I/II) Squamous Cell Carcinoma of Head and Neck


This is a phase I/II study of second primary tumor prevention in early stage (stage I/II)
patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).

The study will evaluate the effect on cells and clinical response to study medications:
Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774,
Tarceva™ ), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib). The side effects of the
medications will be assessed, and chemicals in the cells will be evaluated both before and
after medication is administered that may show how the drugs work. This information will
help researchers determine whether additional studies with these drugs should be conducted
to determine if the drugs can help prevent pre-cancerous lesions from becoming cancerous.

SCCHN accounts for 5% of all cancer, and there is an incidence of approximately 37,200 new
cases in the United States per year with 11,000 deaths. The five-year survival rate for
patients with SCCHN in the United States and other developed countries is still poor,
approximately 40%, comparable to the five-year survival rate in the 1970s despite advances
in detection, surgery, radiation, and chemotherapy. Thus, a preventative approach before
the development of invasive cancer or second primary tumors (SPTs) is highly desirable and
novel strategies to reduce cancer incidence in SCCHN and other tobacco-carcinogen related
malignancies are being pursued.

Approximately 82 patients will participate at the Emory Winship Cancer Institute, Emory
Crawford Long Hospital, and Grady Memorial Hospital in Atlanta, Georgia.


Inclusion Criteria:



- Patients must have, or have previously had, stage I (T1NO) or stage II (T2NO)
squamous cell carcinoma of the head and neck.

- Tumor sites include oral cavity (buccal mucosal, gingival, floor of mouth,
dorsal/ventral tongue, pharyngeal wall), oropharynx, larynx (glottis, supraglottis,
subglottis, epiglottis) hypopharynx, paranasal sinus and nasal cavity.

- May have oral pre-malignant lesions (i.e., hyperplasia, dysplasia, carcinoma in situ)
provided their Stage I or II disease has been definitively treated.

- Must have been free of disease for a minimum period of 8 weeks up to maximum of 3
years following completion of surgery and/or radiotherapy.

- Must have an ECOG/Zubrod performance status of 0-1.

- Patients must be 18 years of age or greater.

- Female patients of childbearing potential must practice adequate contraception and
have a negative pregnancy test (β-HCG).

- Must be able to swallow the Erlotinib and Celecoxib pills.

- Final eligibility for a clinical trial is determined by the health professionals
conducting the trial.

Exclusion Criteria:

- Acute intercurrent illness or those who had surgery within the preceding 4 weeks
unless they have fully recovered.

- History of previous malignancies other than squamous cell carcinoma of the head and
neck unless the cancer was non-melanoma skin cancer.

- Participants who are pregnant or breast feeding.

- Documented history of coagulopathy and/or those taking warfarin or
warfarin-derivative anticoagulants within 6 months of entry into the study.

- Hypertension not adequately controlled by medication as shown by a systolic ≥180 @
screening.

- Documented history of interstitial lung disease.

- Known connective tissue disease.

- Participated in a clinical trial of an investigational drug within 12 months prior to
enrollment.

- Any active cardiovascular events including angina, unstable angina, palpitation,
tachycardia, arrhythmia, or participant has had a recent CVA (stroke) or Myocardial
Infarction (< 6 months).

- Any history of clinically significant ventricular arrythmias (such as ventricular
tachycardia, ventricular fibrillation, or Torsades de Pointes).

- Final eligibility for a clinical trial is determined by the health professionals
conducting the trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Define biologic dose of Erlotinib and Celecoxib in Erlotinib plus Celecoxib in patients with early stage (I/II) SCCHN. Improve overall survival rate by reducing SPTs and recurrence with combination of Erlotinib and Celecoxib.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Dong Shin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

0405-2006

NCT ID:

NCT00400374

Start Date:

August 2007

Completion Date:

November 2015

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Cancer
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Emory University Winship Cancer InstituteAtlanta, Georgia  30322