Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-06-19

Study Completion Date

2004-04-27

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.

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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.

Conditions

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Cervical Cancer Precancerous Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm I

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

Group Type EXPERIMENTAL

Eflornithine

Intervention Type DRUG

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

Arm II

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

Group Type EXPERIMENTAL

Eflornithine

Intervention Type DRUG

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

Arm III

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Patients receive oral placebo daily for 28 days.

Interventions

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Eflornithine

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

Intervention Type DRUG

Placebo

Patients receive oral placebo daily for 28 days.

Intervention Type OTHER

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