RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of eflornithine may be an effective way to
prevent the recurrence of or further development of cervical cancer.
PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in
preventing cervical cancer in patients who have 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
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
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
1) Patients may not have had a prior malignancy.