Erlotinib Hydrochloride in Preventing Cancer in Patients With Precancerous Lesions of the Lung
A Phase I Study of Erlotinib in Patients With Premalignant Lesions of the Lung
8 other identifiers
interventional
60
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2009
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 13, 2009
CompletedFirst Posted
Study publicly available on registry
November 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFebruary 18, 2015
April 1, 2014
2.3 years
November 13, 2009
February 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the ratio of p-EGFR to total EGFR
Baseline up to 90 days
Secondary Outcomes (4)
Change in the expression of p-Akt
Baseline up to 90 days
Change in the expression of p-Erk
Baseline up to 90 days
Change in the expression of Ki67
Baseline up to 90 days
Incidence of toxicities, graded according to Common Toxicity Criteria, version 3.0
Up to 30 days
Other Outcomes (2)
PK/PD parameters
Up to 90 days
Pharmacogenomic profile
Up to 90 days
Study Arms (1)
Prevention (erlotinib hydrochloride)
EXPERIMENTALPatients receive erlotinib hydrochloride PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Interventions
Correlative studies
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seema Khan
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2009
First Posted
November 16, 2009
Study Start
October 1, 2009
Primary Completion
February 1, 2012
Study Completion
June 1, 2013
Last Updated
February 18, 2015
Record last verified: 2014-04