Neoplasms

All Conditions

Precancerous Conditions

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Celecoxib

Tyrosine Kinase Inhibitors

Erlotinib Hydrochloride

Cyclooxygenase 2 Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Tyrosine

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.

Erlotinib & Celecoxib

Dong Shin, MD

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.

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.

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

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

Participants received a fixed dose of celecoxib 400 mg orally BID continuously for 6 months. Erlotinib was dose escalated at 3 dose levels of 50, 75, and 100 mg orally every day for 6 months. Dose escalation followed a standard 3+3 escalation design.

Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.

National Institutes of Health (NIH)

Emory University

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.

40-49 years old

50-59 years old

60-69 years old

70-79 years old

80-89 years old

Age, Customized

Sex: Female, Male

One limitation is the small number of patients who were evaluable for response.

Abdominal cramping, Grade 1

Alopecia, Grade 1

Anemia, Grade 1

Anemia, Grade 2

Anxiety, Grade 1

Decreased protein, Grade 1

Leukopenia, Grade 1

Leukopenia, Grade 2

Depression, Grade 1

Diarrhea, Grade 1

Dry eyes, Grade 1

Dry skin, Grade 1

Elevated LDH, Grade 1

Elevated serum creatinine, Grade 1

Elevated serum creatinine, Grade 2

Elevated alkaline phosphatase, Grade 1

Elevated ALT, Grade 1

Elevated AST, Grade 4

Fatigue, Grade 1

Hyperbilirubinemia, Grade 1

Hypercholesterolemia, Grade 1

Hyperglycemia, Grade 1

Hyperglycemia, Grade 2

Hypoalbuminemia, Grade 1

Hypoalbuminemia, Grade 2

Hypocalcemia, Grade 1

Hypoglycemia, Grade 1

Hypoglycemia, Grade 2

Hypokalemia, Grade 1

Hyponatremia, Grade 1

Mouth sores, Grade 1

Mouth sores, Grade 2

Mucositis, Grade 1

Mucositis, Grade 3

Nausea, Grade 1

Neuropathy, Grade 1

Pruritis, Grade 1

Rash, Grade 1

Rash, Grade 3

Shortness of breath, Grade 1

Strep throat, Grade 2

Urosepsis, Grade 3

Vomiting, Grade 1

Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4

Complete remission (CR)

Partial remission (PR)

Progressive disease (PD)

Stable disease (SDi)

Clinical Outcome: Documented Progression

Stage I invasive carcinoma

Stage II oral cavity carcinoma

Invasive squamous cell carcinoma

Recurrent moderate dysplasia

Recurrent severe dysplasia

Recurrent high-grade dysplasia

Complete remission

Clinical Outcome: Progression to a Higher-grade Dysplasia or Carcinoma

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor	NCT00314262	Precancerous Co...	Erlotinib & Cel...	18 Years - 65 Years	Emory University
Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor	NCT00314262	Precancerous Co...	Erlotinib & Cel...	18 Years - 65 Years	Emory University

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