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

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Erlotinib

Celecoxib

About this trial

This is an interventional prevention trial for Head and Neck Cancer focused on measuring Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Emory University Winship Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erlotinib, Celecoxib

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00400374

First Posted

November 15, 2006

Last Updated

March 13, 2018

Sponsor

Emory University

Collaborators

Genentech, Inc., National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00400374

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Genentech, Inc., National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

Head and Neck Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erlotinib, Celecoxib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Other Intervention Name(s)

OSI-774, Tarceva

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Other Intervention Name(s)

SC-58635, Celebrex

Intervention Description

Celecoxib, 400 mg, daily for 6 months.

Primary Outcome Measure Information:

Title

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong Shin, MD

Organizational Affiliation

Emory University Winship Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Winship Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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