Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Biomarker/Laboratory analysis, Prevention Active 18 and over Other 0405-2006 NCT00400374

Trial Description

Summary

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).

Further Study Information

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.

Eligibility Criteria

Inclusion Criteria:

• Patients must have 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, tongue, pharyngeal wall), oropharynx, larynx and hypopharynx.

• May have oral pre-malignant lesions (i.e., hyperplasia, dysplasia) for cytrobrush to study biomarker modulation.

• Must have been free of disease for a minimum 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 within 72 hours before receiving treatment.

• Participants must be disease free, non-smokers and otherwise healthy.

• Must be able to swallow the pills of Erlotinib and Celecoxib.

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

Exclusion Criteria:

• Patients having hyperplasia, mild dysplasia, and carcinoma in situ, unless those patients have been offered standard therapy (i.e., surgery).

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

• History of previous malignancies unless the cancer was stage 1 or II and rendered free of disease more than 1 year.

• Participants who are pregnant or breast feeding.

• History of recent myocardial infarction (< 6 months).

• Documented history of coagulopathy and/or those taking warfarin or warfarin-derivative anticoagulants.

• Hypertension not adequately controlled by medication.

• 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.

• History of coronary artery disease or cerebrovascular disease.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Winship Cancer Institute of Emory University

Dong Shin, MD

Principal Investigator

Dong Shin, MD		Ph: (888) 946-7447
		Email: dong.shin@emoryhealthcare.org

U.S.A.
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Dong Shin, MD	Ph: 888-946-7447
		Dong Shin, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00400374
Information obtained from ClinicalTrials.gov on October 02, 2008