Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

OBJECTIVES: I. Compare the efficacy of eflornithine versus placebo in causing regression in
patients with cervical intraepithelial neoplasia. II. Compare the qualitative and
quantitative toxicities of these treatment regimens in these patients. III. Establish the
biochemical tissue markers of DNA content, PCNA, the ras oncogene, EGFR, and keratin and
involucrin as intermediate biomarker end points for squamous carcinogenesis in these
patients.

OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to
one of three treatment arms. Arm I-II: Patients receive one of two different doses of oral
eflornithine daily. Arm III: Patients receive oral placebo daily. Treatment continues for 28
days in the absence of disease progression or unacceptable toxicity. Patients are followed at
28 days, and then at 6, 12, 18, and 24 months.

PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this
study.

Inclusion Criteria:

1) Women with newly diagnosed or recurrent CIN grade 2-3, involving an area 3times larger
than the biopsy site. Patients must be > 18 years old, with a performance status less than
or equal to 2 (Zubrod Scale) and a predicted life expectancy of greater than or equal to 12
months. Patients must have a medically safe form of contraception for the duration of the
study. All patients must complete the of pretreatment evaluation, consent to colposcopy and
cervical biopsy for histologic evaluation

Exclusion Criteria:

1) Patients may not have had a prior malignancy.