Clinical trial · Interventional
Secondary Primary Tumor Prevention With EGFR, OSI-774, and Cyclooxygenase-2
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
NCT00400374CI-TRIAL-00032094completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erlotinib, Celecoxib
- interventionNames
- Drug: Erlotinib
- Drug: Celecoxib
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- 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.
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKim P, Saba NF, McCook-Veal A, Liu Y, Klein AM, Beitler JJ, Chen A, Khuri FR, Shin DM. Prospective Pilot Study of Second Primary Tumor Prevention With Erlotinib and Celecoxib in Early-Stage Squamous Cell Carcinoma of the Head and Neck: Long-Term Follow-Up. Head Neck. 2025 Sep;47(9):2594-2602. doi: 10.1002/hed.28178. Epub 2025 Apr 28. PMID 40296503