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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborators: Genentech, Inc.; National Cancer Institute (NCI)
• Treatments: Celecoxib; Erlotinib Hydrochloride

Criteria

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 (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.

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.