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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dong Shin, Emory University
ClinicalTrials.gov Identifier:
NCT00314262
First received: April 11, 2006
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Precancerous Conditions
Drug: Erlotinib & Celecoxib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Effect on cells and patient response to study medications and assess the side effects of these medications. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate chemicals in the cells that may tell how the drug works, before and after receiving the study medications. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 61
Study Start Date: October 2006
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: 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.

Other Name: OSI-774, Tarceva

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314262

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Dong Shin, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Dong Shin, MD, Emory University
ClinicalTrials.gov Identifier: NCT00314262     History of Changes
Other Study ID Numbers: 0596-2004
Study First Received: April 11, 2006
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Emory University:
Skin Lesions
Premalignant Lesion

Additional relevant MeSH terms:
Precancerous Conditions
Neoplasms
Celecoxib
Cyclooxygenase 2 Inhibitors
Erlotinib
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014