Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer, Precancerous Condition

Intervention / Treatment
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* Drug: Eflornithine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Comparison of Eflornithine versus Placebo | 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. | 28 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, Eflornithine