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

NCT00400374 | Completed Phase 1 DMC

• 2 other identifiers: IRB000218515R01CA112643
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Erlotinib, Celecoxib

EXPERIMENTAL

Drug: Erlotinib; Drug: Celecoxib

Interventions

Erlotinib DRUG

Patients will be given Erlotinib (dose escalation from 50 mg, 75 mg, and 100 mg) once daily continuously for 6 months.

Also known as: OSI-774, Tarceva

Erlotinib, Celecoxib

Celecoxib DRUG

Celecoxib, 400 mg, daily for 6 months.

Also known as: SC-58635, Celebrex

Erlotinib, Celecoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Emory University: lead
• Genentech, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Kim 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 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Erlotinib Hydrochloride; Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Dong Shin, MD

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2006
• First Posted: November 16, 2006
• Study Start: August 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: November 1, 2016
• Last Updated: March 15, 2018

Record last verified: 2018-03

Locations

US (1)