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Celecoxib and Erlotinib in Treating Former Smokers With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

2014-08-27 03:54:10 | BioPortfolio

Summary

RATIONALE: Celecoxib and erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating former smokers with stage IIIB, stage IV, recurrent, or progressive non-small cell lung cancer

Description

OBJECTIVES:

Primary

- Determine the clinical toxicity and tolerability of celecoxib and erlotinib hydrochloride in former smokers with stage IIIB or IV or recurrent or progressive non-small cell lung cancer.

Secondary

- Determine the tumor response rate in patients treated with this regimen.

- Determine the dose of celecoxib that results in maximal induction of apoptosis, maximal inhibition of prostaglandin E_2 (PGE_2) in bronchoalveolar fluid, and maximal inhibition of bronchial cell proliferation in patients treated with this regimen.

OUTLINE: This is an open-label, dose-escalation study of celecoxib.

Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 6 additional patients are treated at the MTD.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 6-45 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

celecoxib, erlotinib hydrochloride

Location

Duke Comprehensive Cancer Center
Durham
North Carolina
United States
27710

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:10-0400

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Medical and Biotech [MESH] Definitions

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.

Tumors or cancer of the LUNG.

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.

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