Erlotinib Hydrochloride in Preventing Cancer in Patients With Precancerous Lesions of the Lung

Stopped early · Phase 1

Conditions studied: Dysplasia, Metaplasia, Pulmonary Precancerous Condition

In brief

This phase I trial studies the side effects and best dose of erlotinib hydrochloride in preventing cancer in patients with precancerous lesions of the lung. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID: NCT01013831
Run by: National Cancer Institute (NCI)
People needed: 60
Starts: 2009-10-01
Expected to finish: 2013-06-01
Last updated by the study team: 2015-02-18

Who can join

Age: 40 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of a premalignant lung lesion (metaplasia or dysplasia) on autofluorescent bronchoscopy (AFB) within 1 month
Participants must have a >= 10 pack year lifetime smoking history; current and former smokers only are eligible for this trial
No contraindications for treatment with erlotinib or additional bronchoscopies
Absolute neutrophil count (ANC) of >= 1.5 x 10\^9/L
Platelet count of >= 100 x 10\^9/L
Creatinine level of less than 1.5 mg/dL
Total bilirubin =< 2.0 mg/dl
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN)
Alkaline phosphatase =< 2.5 x ULN
Must meet Eastern Cooperative Oncology Group (ECOG) performance status criteria of 0-1
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) throughout the duration of the study and for 1 month following cessation of study drug; females must begin adequate contraception immediately following screening pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately; if she is pregnant, she will be immediately withdrawn from the study
Ability to understand and the willingness to sign a written institutional review board (IRB) approved informed consent document

You may not qualify if…

Subjects with life-threatening medical conditions that would preclude the treatment intervention and bronchoscopy, including, but not limited to, unstable pulmonary function, acute cardiac failure, which is unstable despite medication use; uncontrolled hypertension; uncontrolled diabetes mellitus; unstable coronary artery disease; acute or chronic liver disease, ongoing or active infection; or psychiatric illness/social situations that would limit compliance with study requirements
Participants with evidence of an active cancer or carcinoma in situ, are not eligible
Participants currently taking medications that induce or inhibit the cytochrome P450, family 3, subfamily A, polypeptide 4-7 (CYP3A4-7) enzymes
Participants may not be receiving any other investigational agents within 3 months
Participants taking warfarin
History of allergic reactions attributed to erlotinib, a known hypersensitivity to erlotinib, or agents with a similar chemical or biological composition to erlotinib
Women who are pregnant or lactating are excluded from the study because based on the proposed mechanism of tyrosine kinase inhibition of erlotinib; erlotinib should be assumed to cause fetal harm when administered to a pregnant woman; there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erlotinib
History of interstitial lung disease (ILD)

Where it is running

Northwestern University — Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Boston University School of Medicine — Boston, Massachusetts, United States
Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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