Head and Neck Cancer Clinical Trial
Official title:
Phase I 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
Verified date | March 2018 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a phase I study of second primary tumor prevention in early stage (stage I/II) patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).
Status | Completed |
Enrollment | 10 |
Est. completion date | November 2016 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 Eastern Cooperative Oncology Group (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 (ß-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 cerebrovascular accident (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. |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Winship Cancer Institute | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Genentech, Inc., National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months | ||
Secondary | 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) SCCHN. | 6 months |
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