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

March 13, 2018 updated by: Dong Shin, Emory University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Winship Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erlotinib, Celecoxib
Drug: Erlotinib
Patients will be given Erlotinib (dose escalation from 50 mg, 75 mg, and 100 mg) once daily continuously for 6 months.
Other Names:
  • Tarceva
  • OSI-774
Drug: Celecoxib
Celecoxib, 400 mg, daily for 6 months.
Other Names:
  • Celebrex
  • SC-58635

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)
Genentech, Inc.

Investigators

  • Principal Investigator: Dong Shin, MD, Emory University Winship Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 15, 2006

First Submitted That Met QC Criteria

November 15, 2006

First Posted (Estimate)

November 16, 2006

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00021851
  • 5R01CA112643 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe