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

NCT ID: NCT00314262

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2012-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Precancerous Conditions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Erlotinib & Celecoxib

Group Type: EXPERIMENTAL

Erlotinib & Celecoxib

Intervention Type: DRUG

Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.

Celecoxib given 400 mg orally BID continuously for 6 months.

Interventions

Erlotinib & Celecoxib

Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.

Celecoxib given 400 mg orally BID continuously for 6 months.

Intervention Type: DRUG

Other Intervention Names

OSI-774, Tarceva

Eligibility Criteria

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 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.

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Dong Shin

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong Shin, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Winship Cancer Institute

Locations

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

References

Shin DM, Zhang H, Saba NF, Chen AY, Nannapaneni S, Amin AR, Muller S, Lewis M, Sica G, Kono S, Brandes JC, Grist WJ, Moreno-Williams R, Beitler JJ, Thomas SM, Chen Z, Shin HJ, Grandis JR, Khuri FR, Chen ZG. Chemoprevention of head and neck cancer by simultaneous blocking of epidermal growth factor receptor and cyclooxygenase-2 signaling pathways: preclinical and clinical studies. Clin Cancer Res. 2013 Mar 1;19(5):1244-56. doi: 10.1158/1078-0432.CCR-12-3149. Epub 2013 Feb 19.

Reference Type: BACKGROUND

PMID: 23422093 (View on PubMed)

Saba NF, Hurwitz SJ, Kono SA, Yang CS, Zhao Y, Chen Z, Sica G, Muller S, Moreno-Williams R, Lewis M, Grist W, Chen AY, Moore CE, Owonikoko TK, Ramalingam S, Beitler JJ, Nannapaneni S, Shin HJ, Grandis JR, Khuri FR, Chen ZG, Shin DM. Chemoprevention of head and neck cancer with celecoxib and erlotinib: results of a phase ib and pharmacokinetic study. Cancer Prev Res (Phila). 2014 Mar;7(3):283-91. doi: 10.1158/1940-6207.CAPR-13-0215. Epub 2013 Oct 3.

Reference Type: RESULT

PMID: 24085777 (View on PubMed)

Other Identifiers

IRB00024922

Identifier Type: -

Identifier Source: org_study_id