Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor

Completed · Phase 1/Phase 2

Conditions studied: Precancerous Conditions

In brief

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

Key facts

Study ID

NCT00314262

Run by

Emory University

People needed

17

Starts

2006-10-01

Expected to finish

2012-11-01

Last updated by the study team

2014-10-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Eastern Cooperative Oncology Group (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 prothrombin time (PT)/partial thromboplastin time (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.

You may not qualify if…

• 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 congestive heart failure (CHF) greater than New York Heart Association (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 nonsteroidal antiinflammatory drug (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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.