Official Title: “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).

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Erlotinib, Celecoxib
  • Erlotinib self-administered 100 mg daily 30 days for 6 months. Celecoxib 400 mg, 30 days for 6 months.
• Drug: Erlotinib, Celecoxib
  • Erlotinib, 100 mg, daily for six months. Celecoxib, 400 mg, daily for six months.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1

Primary Measures

• 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.
  • Time Frame: 6 months
    Safety Issue?: Yes

Secondary Measures

• Assess tolerability and toxicity associated with combination of Erlotinib and toxicity associated with combination of Erlotinib and Celecoxib for patients with early stage (I/II) SCCN.
  • Time Frame: 6 months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Emory University

Overall Clinical Trial Officials and Contacts

Dong Shin, MD Principal Investigator Emory University Winship Cancer Institute  

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

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00400374

Study ID Number: 0405-2006

ClinicalTrials.gov Identifier: NCT00400374

Health Authority: United States: Institutional Review Board