Secondary Primary Tumor Prevention With EGFR, OSI-774, and Cyclooxygenase-2
Information source: Emory University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer
Intervention: Erlotinib, Celecoxib (Drug); Erlotinib, Celecoxib (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Emory University Official(s) and/or principal investigator(s):
Dong Shin, MD, Principal Investigator, Affiliation: Emory University Winship Cancer Institute
Overall contact:
Dong Shin, MD, Phone: (888) 946-7447, Email: dong.shin@emoryhealthcare.org
Summary
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).
Clinical Details
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
Study design: Prevention, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Dong Shin, MD, Phone: (888) 946-7447, Email: dong.shin@emoryhealthcare.org
Emory University Winship Cancer Institute, Atlanta, Georgia 30322, United States; Recruiting
Dong Shin, MD, Phone: 888-946-7447
Dong Shin, MD, Principal Investigator
Additional Information
Starting date: November 2006
Ending date: November 2015
Last updated: May 1, 2009
|
