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Erlotinib Hydrochloride in Treating Patients With Previously Treated Non-Small Cell Lung Cancer, Head and Neck Cancer, or Esophageal Cancer and Precancerous Lesions of the Lung

2014-07-23 21:11:48 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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).

Tertiary

- 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Cancer Survivor

Intervention

Erlotinib

Location

Northwestern University
Chicago
Illinois
United States
60611-3013

Status

Recruiting

Source

Northwestern University

Results (where available)

View Results

Links

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.

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