NCT00006079

Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

A Randomized Double-Blind Study of Alpha-Difluromethylornithine (DFMO) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Cancer
• Precancerous Condition

Interventions

Type	Name	Description
DRUG	Eflornithine	Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.
OTHER	Placebo	Patients receive oral placebo daily for 28 days.

Timeline

• Start date: 1998-06-19
• Primary completion: 2004-04-27
• Completion: 2004-04-27
• First posted: 2004-05-26
• Last updated: 2018-10-25

Locations

1 site across 1 country: United States