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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01013831
Phase
PHASE1
Status
Terminated

Conditions

  • Dysplasia
  • Metaplasia
  • Pulmonary Precancerous Condition

Eligibility Criteria

Sex
ALL
Age
40 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib Hydrochloride — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

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 Dates

First listed
Nov 16, 2009
Start date
Oct 31, 2009
Status verified
Apr 2014
Primary completion
Feb 29, 2012
Completion
Jun 30, 2013

Study Design

Enrollment
60 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Prevention (erlotinib hydrochloride)
    Patients receive erlotinib hydrochloride PO QD for 90 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Change in the ratio of p-EGFR to total EGFR [ Time Frame: Baseline up to 90 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Boston University School of MedicineBostonMassachusetts02118-
Roswell Park Cancer InstituteBuffaloNew York14263-

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