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Phase I/II Study of Chemoprevention With Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Premalignant Lesions of Head and Neck of Former Smokers


Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Precancerous Conditions

Thank you

Trial Information

Phase I/II Study of Chemoprevention With Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Premalignant Lesions of Head and Neck of Former Smokers


The purpose of this study is to evaluate the effect on cells and patient response to study
medications, assess the side effects of these medications, and to evaluate chemicals in the
cells that may tell how the drug works, before, and after receiving the study medications.

Approximately 61 patients will participate at Emory Winship Cancer Institute and Emory
Crawford W. Long Hospital in Atlanta, Georgia.


Inclusion Criteria:



- Participants must have premalignant lesions.

- Lesion sites include oral cavity, oropharynx, and larynx.

- Must have at least a >20 pack-year history of smoking.

- Must have a ECOG/Zubrod performance status of 0-1.

- Participants must be 18 years of age or older.

- No contraindications for laryngoscopy and biopsy.

- Adequate liver function.

- Must have hemoglobin and hematocrit levels at or above the lower limit of the normal
range.

- Participants must have PT/PTT levels at or above the lower limit of the normal range.

- Women of child-bearing potential must have a negative serum pregnancy test within 72
hours of receiving treatment.

- Must be able to swallow the oral dose of erlotinib and celecoxib.

- Participants must be disease free.

- Final eligibility will be determined by the health professionals conducting the
trial.

Exclusion Criteria:

- Participants with acute intercurrent illness or those who had surgery within the
preceding 4 weeks unless they have fully recovered.

- History of previous malignancies unless the cancer was stage I or II and rendered
free of disease more than 1 year.

- Pregnant or breast feeding.

- Not practicing adequate contraception if the participants are of child bearing
potential.

- Female patients who have a positive pregnancy test.

- History or recent myocardial infarction.

- Hypertension not adequately controlled by medication.

- Documented history of coagulopathy.

- Documented history of CHF greater than NYHA Grade II.

- Participants who were taking COX-2 inhibitors or EGFR tyrosine kinase inhibitors
within 3 months of study entry.

- Documented history or interstitial lung disease.

- Known connective tissue disease.

- History of NSAID-induced ulcers or those who are at risk for a GI ulcer.

- Participated in a clinical trial of an investigational drug within 12 months prior to
enrollment.

- Final eligibility will be determined by the health professionals conducting the
trial.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Effect on cells and patient response to study medications and assess the side effects of these medications.

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Dong Shin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

0596-2004

NCT ID:

NCT00314262

Start Date:

October 2006

Completion Date:

November 2013

Related Keywords:

  • Precancerous Conditions
  • Skin Lesions
  • Premalignant Lesion
  • Precancerous Conditions

Name

Location

Emory University Winship Cancer InstituteAtlanta, Georgia  30322