Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00006079

Collaborator

National Cancer Institute (NCI) (NIH)

150

Enrollment

Location

Arms

70.3

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Precancerous Condition	Drug: Eflornithine Other: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 19, 1998

Actual Primary Completion Date :

Apr 27, 2004

Actual Study Completion Date :

Apr 27, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.	Drug: Eflornithine Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.
Experimental: Arm II Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.	Drug: Eflornithine Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.
Placebo Comparator: Arm III Arm III: Patients receive oral placebo daily. Treatment continues for 28 days.	Other: Placebo Patients receive oral placebo daily for 28 days.

Arm

Intervention/Treatment

Experimental: Arm I

Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.

Drug: Eflornithine

Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.

Experimental: Arm II

Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days.

Drug: Eflornithine

Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.

Placebo Comparator: Arm III

Arm III: Patients receive oral placebo daily. Treatment continues for 28 days.

Other: Placebo

Patients receive oral placebo daily for 28 days.

Outcome Measures

Primary Outcome Measures

Efficacy Comparison of Eflornithine versus Placebo [28 Days]
Efficacy in causing regression in patients with cervical intraepithelial neoplasia measured by absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, and then at 6, 12, 18, and 24 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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