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

Sponsor:	Emory University
Information provided by (Responsible Party):	Omer Kucuk, 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 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Celecoxib Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

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:	August 2007
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: Erlotinib, Celecoxib Erlotinib self-administered 100 mg daily 30 days for 6 months. Celecoxib 400 mg, 30 days for 6 months. Other Name: OSI-774, Cyclooxygenase-2 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

Locations

United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Omer Kucuk, MD

Emory University Winship Cancer Institute

More Information

No publications provided

Responsible Party:	Omer Kucuk, MD, Emory University
ClinicalTrials.gov Identifier:	NCT00400374 History of Changes
Other Study ID Numbers:	0405-2006
Study First Received:	November 15, 2006
Last Updated:	March 26, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Head and Neck Cancer

Additional relevant MeSH terms:

Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
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
Central Nervous System Agents
Antirheumatic Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 22, 2012