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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00400374 |
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).
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: Erlotinib, Celecoxib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 82 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2015 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dong Shin, MD | (888) 946-7447 | dong.shin@emoryhealthcare.org |
United States, Georgia | |
Emory University Winship Cancer Institute | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Dong Shin, MD 888-946-7447 | |
Principal Investigator: Dong Shin, MD |
Principal Investigator: | Dong Shin, MD | Emory University Winship Cancer Institute |
Responsible Party: | Winship Cancer Institute ( Dong Shin, MD ) |
Study ID Numbers: | 0405-2006 |
Study First Received: | November 15, 2006 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00400374 History of Changes |
Health Authority: | United States: Institutional Review Board |
Head and Neck Cancer |
Erlotinib Anti-Inflammatory Agents Celecoxib Cyclooxygenase Inhibitors Squamous Cell Carcinoma Cyclooxygenase 2 Inhibitors Protein Kinase Inhibitors Carcinoma Analgesics, Non-Narcotic |
Head and Neck Neoplasms Epidermoid Carcinoma Neoplasm Metastasis Mitogens Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Carcinoma, Squamous Cell |
Anti-Inflammatory Agents Erlotinib Celecoxib Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Cyclooxygenase 2 Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Neoplasms |
Neoplasms by Site Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Head and Neck Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |