Status:
COMPLETED
Secondary Primary Tumor Prevention With EGFR, OSI-774, and Cyclooxygenase-2
Lead Sponsor:
Emory University
Collaborating Sponsors:
Genentech, Inc.
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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).
Detailed Description
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). The study will evaluate the effect...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00400374
Start Date
August 1 2007
End Date
November 1 2016
Last Update
March 15 2018
Active Locations (1)
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1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322