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

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00400374

Purpose

This is a phase I/II study of second primary tumor prevention in early stage (stage I/II) patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Erlotinib, Celecoxib	Phase I Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Celecoxib Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II 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

Further study details as provided by Emory University:

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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) SCCN. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	82
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Erlotinib, Celecoxib Erlotinib self-administered 100 mg daily 30 days for 6 months. Celecoxib 400 mg, 30 days for 6 months. Drug: Erlotinib, Celecoxib Erlotinib, 100 mg, daily for six months. Celecoxib, 400 mg, daily for six months.

Detailed Description:

This is a phase I/II 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.

Approximately 82 patients will participate at the Emory Winship Cancer Institute, Emory Crawford Long Hospital, and Grady Memorial Hospital in Atlanta, Georgia.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have 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, tongue, pharyngeal wall), oropharynx, larynx and hypopharynx.
May have oral pre-malignant lesions (i.e., hyperplasia, dysplasia) for cytrobrush to study biomarker modulation.
Must have been free of disease for a minimum of 8 weeks up to maximum of 3 years following completion of surgery and/or radiotherapy.
Must have an 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 within 72 hours before receiving treatment.
Participants must be disease free, non-smokers and otherwise healthy.
Must be able to swallow the pills of Erlotinib and Celecoxib.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria:

Patients having hyperplasia, mild dysplasia, and carcinoma in situ, unless those patients have been offered standard therapy (i.e., surgery).
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 1 or II and rendered free of disease more than 1 year.
Participants who are pregnant or breast feeding.
History of recent myocardial infarction (< 6 months).
Documented history of coagulopathy and/or those taking warfarin or warfarin-derivative anticoagulants.
Hypertension not adequately controlled by medication.
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.
History of coronary artery disease or cerebrovascular disease.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400374

Contacts

Contact: Dong Shin, MD

(888) 946-7447

dong.shin@emoryhealthcare.org

Locations

United States, Georgia
Emory University Winship Cancer Institute	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Dong Shin, MD 888-946-7447
Principal Investigator: Dong Shin, MD

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Dong Shin, MD

Emory University Winship Cancer Institute

More Information

No publications provided

Responsible Party:	Winship Cancer Institute ( Dong Shin, MD )
Study ID Numbers:	0405-2006
Study First Received:	November 15, 2006
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00400374 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Head and Neck Cancer

Study placed in the following topic categories:

Erlotinib
Anti-Inflammatory Agents
Celecoxib
Cyclooxygenase Inhibitors
Squamous Cell Carcinoma
Cyclooxygenase 2 Inhibitors
Protein Kinase Inhibitors
Carcinoma
Analgesics, Non-Narcotic

Head and Neck Neoplasms
Epidermoid Carcinoma
Neoplasm Metastasis
Mitogens
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Carcinoma, Squamous Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Erlotinib
Celecoxib
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cyclooxygenase 2 Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Head and Neck Neoplasms
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009