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RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib hydrochloride in treating patients with previously treated non-small cell lung cancer, head and neck cancer, or esophageal cancer with precancerous lesions of the lung.
- To determine the toxicity and safety of multiple low doses of erlotinib hydrochloride in patients with a history of previously treated aerodigestive cancer and a recently diagnosed premalignant lesion of the lung.
- To determine the efficacy of each dose level of erlotinib hydrochloride on the modulation of molecular markers in lung biopsies.
- To determine the significance of the change in expression of primary biomarkers (total epidermal growth factor receptor [EGFR] and phosphorylated-EGFR [p-EGFR]) between pre- and post-treatment lung biopsies.
- To determine the significance of the change in expression of secondary biomarkers (p-Akt, p-Erk, Ki67, and Bcl2).
- To model the responses to treatment by evaluating the pharmacokinetics/pharmacodynamics of erlotinib hydrochloride, the polymorphisms in the EGFR gene and in genes responsible for erlotinib hydrochloride metabolism and transport, and the optimal biologic concentration of erlotinib hydrochloride.
OUTLINE: Patients are stratified according to smoking status (current vs former/never smokers).
Patients receive oral erlotinib hydrochloride once daily for 90 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for correlative biomarker, pharmacokinetic, and pharmacogenetic studies.
After completion of study treatment, patients are followed up at 30 days.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Published on BioPortfolio: 2014-07-23T21:11:48-0400
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A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.
A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)
A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
That portion of the stomach remaining after gastric surgery, usually gastrectomy or gastroenterostomy for cancer of the stomach or peptic ulcer. It is a common site of cancer referred to as stump cancer or carcinoma of the gastric stump.
A voluntary organization concerned with the prevention and treatment of cancer through education and research.
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