Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer

PRIMARY OBJECTIVES:

I. To determine the relationship between urinary deuterated ([D10]) phenanthrene tetraol
(PheT) level, PheT:phenanthrols (HOPhe) ratio, and the presence of bronchoepithelial
metaplasia and/or dysplasia in smokers who have undergone screening bronchoscopy at Roswell
Park Cancer Institute (RPCI).

OUTLINE:

Patients receive deuterated phenanthrene tetraol orally (PO). Urine samples are collected for
laboratory studies for 6 hours after dosing.

- Current or former smoker

- 18 years of age or older

- Documentation of a diagnosis of no dysplasia, dysplasia, or metaplasia on bronchoscopy
(white light and/or autofluorescence) conducted less than or equal to 10 years prior
to registration

- Not pregnant or breastfeeding

- Able to provide written informed consent indicating an understanding of the nature of
the study

- Willing to comply with study requirements, including taking [D10]phenanthrene in water
with 20% ethanol

- No previous history of aerodigestive cancer

- Not currently undergoing treatment for any cancers. Exception: basal cell or squamous
cell skin cancer

- Not currently taking any other investigational agents

- No history of allergic reaction to [D10]phenanthrene or similar compounds

- No major medical comorbidities, for example, renal dysfunction, heart function, and
diabetes, to be adjudicated by study physicians

- Not a former or recovering alcoholic

- No use of metronidazole or antabuse less than or equal to 7 days prior to
[D10]phenanthrene dosing, as they could potentially interact with ethanol