Secondary Primary Tumor Prevention With EGFR, OSI-774, and Cyclooxygenase-2

Completed · Phase 1

Conditions studied: Head and Neck Cancer

In brief

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).

Key facts

Study ID

NCT00400374

Run by

Emory University

People needed

10

Starts

2007-08-01

Expected to finish

2016-11-01

Last updated by the study team

2018-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (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.

You may not qualify if…

• 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.

Where it is running

• Emory University Winship Cancer Institute — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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