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 — DRUGGiven PO
- Laboratory Biomarker Analysis — OTHERCorrelative studies
- Pharmacological Study — OTHERCorrelative 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | - |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | - |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | - |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | - |
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