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Head and Neck CancerPhase 1NCT00400374

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

A Phase 1 study testing Erlotinib and Celecoxib in people with Head and Neck Cancer, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Erlotinib and Celecoxib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Aug 2007to Nov 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: 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

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).

Read the 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 on cells and clinical response to study medications: Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva™), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib). The side effects of the medications will be assessed, and chemicals in the cells will be evaluated both before and after medication is administered that may show how the drugs work. This information will help researchers determine whether additional studies with these drugs should be conducted to determine if the drugs can help prevent pre-cancerous lesions from becoming cancerous.

SCCHN accounts for 5% of all cancer, and there is an incidence of approximately 37,200 new cases in the United States per year with 11,000 deaths. The five-year survival rate for patients with SCCHN in the United States and other developed countries is still poor, approximately 40%, comparable to the five-year survival rate in the 1970s despite advances in detection, surgery, radiation, and chemotherapy. Thus, a preventative approach before the development of invasive cancer or second primary tumors (SPTs) is highly desirable and novel strategies to reduce cancer incidence in SCCHN and other tobacco-carcinogen related malignancies are being pursued.

Being tested
Erlotinib, Celecoxib
Keywords
Head and Neck Cancer
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErlotinibDrug

    Also called OSI-774, Tarceva

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

  • CelecoxibDrug

    Also called SC-58635, Celebrex

    Celecoxib, 400 mg, daily for 6 months.

Study groups in NCT00400374
Study groupRoleWhat they receive
Erlotinib, CelecoxibExperimentalNot described
Receives: Drug: Erlotinib; Drug: Celecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (1)

  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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2006 (estimated)
  2. Study startAug 2007
  3. Primary completionDec 2012
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00400374
Sponsor's protocol ID
IRB00021851
Other IDs
5R01CA112643
Status last verified
Mar 2018
First submitted
15 Nov 2006
Last updated
15 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40296503

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Erlotinib and Celecoxib in people with Head and Neck Cancer, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00400374, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.

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